Hepatitis B, Chronic
Conditions
Brief summary
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to \<18 years at baseline) with HBeAg positive chronic hepatitis B. Children without advanced fibrosis and without cirrhosis will be randomized 2:1 to treatment Group A, receiving Pegasys 45-180 mcg subcutaneously weekly for 48 weeks, or to the untreated control Group B. Children with advanced fibrosis will be assigned to treatment group C and receive 48 weeks of treatment with Pegasys. Children in the untreated control Group B who have not experienced seroconversion 48 weeks after randomization may enter the Switch Arm to receive 48 weeks of Pegasys treatment. This offer will be available for 1 year following 48 weeks from randomization. Anticipated time on study treatment is 48 weeks. All subjects will be followed up for 5 years after the end of treatment (A,C,Switch)/principal observation (B) period.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients, 3 years to \<18 years of age at baseline * Positive HBsAg for more than 6 months * Positive HBeAg and detectable HBV DNA at screening * A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous therapy for hepatitis B) to confirm the presence of advanced fibrosis or exclude cirrhosis * Compensated liver disease (Child-Pugh Class A) * Elevated serum alanine transferase (ALT) * Normal thyroid gland function at screening
Exclusion criteria
* Subjects with cirrhosis * Subjects must not have received investigational drugs or licensed treatments with anti-HBV activity within 6 months of baseline. Subjects who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded * Known hypersensitivity to peginterferon * Positive test results at screening for hepatitis A, hepatitis C, hepatitis D or HIV infection * History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis B * History or evidence of bleeding from esophageal varices * Decompensated liver disease (e.g. ascites, Child-Pugh Class B or C) * History of immunologically mediated disease * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B | Week 48 | The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B | Week 48 | HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B | Week 48 | The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Normal ALT at EOT/POP in Groups A and B | Week 48 | Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Quantitative Serum ALT Level in Groups A and B | Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBV DNA Level in Groups A and B | Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment. |
| Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population |
| Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBeAg Seroconversion at EOT in Group C | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Loss of HBeAg at EOT in Group C | Week 48 | The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBsAg Seroconversion at EOT in Group C | Week 48 | HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Loss of HBsAg at EOT in Group C | Week 48 | The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Normal ALT at EOT in Group C | Week 48 | Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With HBV DNA Undetectable at EOT in Group C | Week 48 | HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C | Week 48 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Quantitative Serum ALT Level in Group C | Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBV DNA Level in Group C | Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBV DNA Level in Group C | Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category | Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall) | AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h\*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. Number of subjects analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table. |
| Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall) | The percentage of participants with \>15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBeAg Level in Groups A and B | Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBsAg Level in Groups A and B | Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBeAg Level in Group C | Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Quantitative HBsAg Level in Group C | Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. |
| Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | Week 48; FU Week 24 (up to 72 weeks overall) | Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. |
| Change From Baseline in Height for Age Z-Score in Groups A and B | Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall) | The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Weight for Age Z-Score in Groups A and B | Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Height for Age Z-Score in Group C | Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall) | The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. |
| Change From Baseline in Weight for Age Z-Score in Group C | Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population. |
| Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBeAg Level in Groups A and B | Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBsAg Level in Groups A and B | Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative Serum ALT Level in Group C | Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall) | The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBeAg Level in Group C | Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table. |
| Change From Baseline in Quantitative HBsAg Level in Group C | Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall) | The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. |
| Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Baseline, FU Years: 1, 2, 3, 4, 5 | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B | FU Week 24 (up to 72 weeks overall) | The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received. |
| Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received. |
| Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
| Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group | FU Week 24 (up to 72 weeks overall) | The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population. |
Countries
Australia, Belgium, Bulgaria, China, Germany, Israel, Italy, Poland, Russia, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 211 individuals were screened for entry into the study. Of these, there were 161 participants enrolled in the study and included in the main analyses.
Participants by arm
| Arm | Count |
|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on BSA and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 square meters (m\^2), 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; greater than (\>) 1.51 m\^2, 180 mcg. | 101 |
| Group B: Untreated Control Without Advanced Fibrosis Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B. | 50 |
| Group C: PEG-IFN Monotherapy With Advanced Fibrosis Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51-0.53 m\^2, 45 mcg; 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. | 10 |
| Total | 161 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal from the study | 26 | 22 | 5 |
Baseline characteristics
| Characteristic | Group B: Untreated Control Without Advanced Fibrosis | Total | Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Group C: PEG-IFN Monotherapy With Advanced Fibrosis |
|---|---|---|---|---|
| Age, Continuous | 11.2 years STANDARD_DEVIATION 5.01 | 10.55 years STANDARD_DEVIATION 4.81 | 10.41 years STANDARD_DEVIATION 4.57 | 6.7 years STANDARD_DEVIATION 3.27 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 30 Participants | 79 Participants | 48 Participants | 1 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 20 Participants | 82 Participants | 53 Participants | 9 Participants |
| Age, Customized From 65-84 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 18 Participants | 57 Participants | 37 Participants | 2 Participants |
| Sex: Female, Male Male | 32 Participants | 104 Participants | 64 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 101 | 0 / 49 | 0 / 10 | 0 / 33 | 0 / 101 | 0 / 49 | 0 / 10 | 0 / 33 |
| other Total, other adverse events | 80 / 101 | 18 / 49 | 9 / 10 | 21 / 33 | 25 / 101 | 6 / 49 | 0 / 10 | 27 / 33 |
| serious Total, serious adverse events | 6 / 101 | 1 / 49 | 0 / 10 | 2 / 33 | 0 / 101 | 0 / 49 | 0 / 10 | 0 / 33 |
Outcome results
Primary
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B | 25.7 percentage of participants | 95% Confidence Interval 17.56 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at 24 Weeks After End of Treatment (EOT)/POP in Groups A and B | 6 percentage of participants | 95% Confidence Interval 1.25 |
Comparison: Analysis stratified by hepatitis B virus (HBV) genotype A versus non-A genotypes and alanine aminotransferase (ALT) less than (\<) 5 times (×) upper limit of normal (ULN) versus greater than or equal to (≥) 5 × ULN at Baseline. The OR was calculated using Group B as reference.p-value: =0.004395% CI: [1.54, 19.2]Cochran-Mantel-Haenszel
p-value: =0.3732Breslow-Day
Secondary
Change From Baseline in Height for Age Z-Score in Group C
The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | Baseline | 0.586 standard deviations | Standard Deviation 0.947 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | Week 12 | 0.07 standard deviations | Standard Deviation 0.492 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | Week 24 | 0.262 standard deviations | Standard Deviation 0.42 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | Week 36 | 0.3 standard deviations | Standard Deviation 0.601 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | Week 48 | 0.19 standard deviations | Standard Deviation 0.683 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | FU Week 12 | 0.205 standard deviations | Standard Deviation 0.611 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Group C | FU Week 24 | 0.064 standard deviations | Standard Deviation 0.634 |
Secondary
Change From Baseline in Height for Age Z-Score in Groups A and B
The difference between the population mean and raw scores was calculated as the height for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 24 | -0.04 standard deviations | Standard Deviation 0.293 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 48 | -0.099 standard deviations | Standard Deviation 0.365 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 12 | 0.011 standard deviations | Standard Deviation 0.258 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | FU Week 12 | -0.112 standard deviations | Standard Deviation 0.404 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 36 | -0.056 standard deviations | Standard Deviation 0.337 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | FU Week 24 | -0.117 standard deviations | Standard Deviation 0.429 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Baseline | 0.271 standard deviations | Standard Deviation 1.149 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | FU Week 24 | -0.079 standard deviations | Standard Deviation 0.282 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Baseline | -0.062 standard deviations | Standard Deviation 1.17 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 12 | -0.006 standard deviations | Standard Deviation 0.185 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 24 | -0.071 standard deviations | Standard Deviation 0.264 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 36 | -0.025 standard deviations | Standard Deviation 0.328 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | Week 48 | -0.013 standard deviations | Standard Deviation 0.284 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Height for Age Z-Score in Groups A and B | FU Week 12 | -0.037 standard deviations | Standard Deviation 0.243 |
Secondary
Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C
Liver elastography was performed to assess elasticity and extent of hepatic fibrosis. The change in LSM from Baseline to each visit was averaged among all participants in expressed in kilopascals (kPa). Positive changes in LSM values corresponded to an increase in stiffness and hepatic fibrosis. Liver Substudy Population: All participants who consented to participate in the liver elasticity substudy. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Week 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | Week 48 | -0.49 kPa | Standard Deviation 2.151 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | FU Week 24 | -1.026 kPa | Standard Deviation 2.269 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | Week 48 | 0.376 kPa | Standard Deviation 2.719 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | FU Week 24 | -0.72 kPa | Standard Deviation 2.633 |
| Group C: PEG-IFN Monotherapy With Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | Week 48 | -1.517 kPa | Standard Deviation 1.685 |
| Group C: PEG-IFN Monotherapy With Advanced Fibrosis | Change From Baseline in Liver Stiffness Measure (LSM) in Groups A, B, C | FU Week 24 | -1.7 kPa | Standard Deviation 1.033 |
Secondary
Change From Baseline in Quantitative HBeAg Level in Group C
The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Group C | Week 12 | -0.779 log10 PEIU/mL | Standard Deviation 0.645 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Group C | Week 24 | -0.817 log10 PEIU/mL | Standard Deviation 0.678 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Group C | Week 36 | -0.817 log10 PEIU/mL | Standard Deviation 0.685 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Group C | Week 48 | -0.762 log10 PEIU/mL | Standard Deviation 0.818 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Group C | FU Week 24 | -0.742 log10 PEIU/mL | Standard Deviation 0.84 |
Secondary
Change From Baseline in Quantitative HBeAg Level in Groups A and B
The change in quantitative HBeAg from Baseline to each visit was averaged among all participants and expressed in log10 PEIU/mL. ITT Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 24 | -0.834 log10 PEIU/mL | Standard Deviation 0.805 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 48 | -1.28 log10 PEIU/mL | Standard Deviation 1.043 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 36 | 1.123 log10 PEIU/mL | Standard Deviation 0.91 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | FU Week 24 | -1.24 log10 PEIU/mL | Standard Deviation 1.205 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 12 | -0.583 log10 PEIU/mL | Standard Deviation 0.672 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | FU Week 24 | -0.452 log10 PEIU/mL | Standard Deviation 0.793 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 12 | -0.225 log10 PEIU/mL | Standard Deviation 0.497 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 24 | -0.261 log10 PEIU/mL | Standard Deviation 0.612 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 36 | -0.3 log10 PEIU/mL | Standard Deviation 0.621 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBeAg Level in Groups A and B | Week 48 | -0.491 log10 PEIU/mL | Standard Deviation 0.74 |
Secondary
Change From Baseline in Quantitative HBsAg Level in Group C
The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.
Time frame: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Group C | Week 12 | -0.397 log10 IU/mL | Standard Deviation 0.428 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Group C | Week 24 | -0.71 log10 IU/mL | Standard Deviation 0.712 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Group C | Week 36 | -0.943 log10 IU/mL | Standard Deviation 0.913 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Group C | Week 48 | -1.01 log10 IU/mL | Standard Deviation 1.019 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Group C | FU Week 24 | -1.088 log10 IU/mL | Standard Deviation 1.141 |
Secondary
Change From Baseline in Quantitative HBsAg Level in Groups A and B
The change in quantitative HBsAg from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 24 | -0.798 log10 IU/mL | Standard Deviation 1.343 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 48 | -1.239 log10 IU/mL | Standard Deviation 1.652 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 36 | -1.051 log10 IU/mL | Standard Deviation 1.534 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | FU Week 24 | -0.936 log10 IU/mL | Standard Deviation 1.491 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 12 | -0.444 log10 IU/mL | Standard Deviation 1.021 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | FU Week 24 | -0.204 log10 IU/mL | Standard Deviation 0.316 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 12 | -0.081 log10 IU/mL | Standard Deviation 0.356 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 24 | -0.032 log10 IU/mL | Standard Deviation 0.392 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 36 | -0.126 log10 IU/mL | Standard Deviation 0.26 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBsAg Level in Groups A and B | Week 48 | -0.188 log10 IU/mL | Standard Deviation 0.285 |
Secondary
Change From Baseline in Quantitative HBV DNA Level in Group C
The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | FU Week 4 | -3.262 log10 IU/mL | Standard Deviation 2.102 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | Week 12 | -2.084 log10 IU/mL | Standard Deviation 1.1 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | Week 24 | -2.267 log10 IU/mL | Standard Deviation 1.595 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | Week 36 | -2.529 log10 IU/mL | Standard Deviation 1.879 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | Week 48 | -2.546 log10 IU/mL | Standard Deviation 2.14 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | FU Week 12 | -3.613 log10 IU/mL | Standard Deviation 2.519 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Group C | FU Week 24 | -4.15 log10 IU/mL | Standard Deviation 2.904 |
Secondary
Change From Baseline in Quantitative HBV DNA Level in Groups A and B
The change in quantitative HBV DNA from Baseline to each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 12 | -1.588 log10 IU/mL | Standard Deviation 1.625 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 24 | -2.112 log10 IU/mL | Standard Deviation 1.996 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 36 | -2.525 log10 IU/mL | Standard Deviation 2.148 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 48 | -2.877 log10 IU/mL | Standard Deviation 2.374 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | FU Week 4 | -2.34 log10 IU/mL | Standard Deviation 2.582 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | FU Week 12 | -2.164 log10 IU/mL | Standard Deviation 2.737 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | FU Week 24 | -2.381 log10 IU/mL | Standard Deviation 2.778 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 12 | -0.156 log10 IU/mL | Standard Deviation 1.093 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 48 | -0.493 log10 IU/mL | Standard Deviation 1.518 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 24 | -0.168 log10 IU/mL | Standard Deviation 1.214 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | FU Week 12 | -0.86 log10 IU/mL | Standard Deviation 2.163 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | Week 36 | -0.359 log10 IU/mL | Standard Deviation 1.411 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative HBV DNA Level in Groups A and B | FU Week 24 | -0.587 log10 IU/mL | Standard Deviation 2.259 |
Secondary
Change From Baseline in Quantitative Serum ALT Level in Group C
The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 1 | 0.313 factor of ULN | Standard Deviation 0.414 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 2 | 0.091 factor of ULN | Standard Deviation 0.991 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 4 | -0.361 factor of ULN | Standard Deviation 1.566 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 8 | -0.101 factor of ULN | Standard Deviation 1.895 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 12 | -0.012 factor of ULN | Standard Deviation 1.613 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 18 | -0.589 factor of ULN | Standard Deviation 0.996 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 24 | -0.917 factor of ULN | Standard Deviation 1.31 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 30 | -0.584 factor of ULN | Standard Deviation 1.73 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 36 | -0.633 factor of ULN | Standard Deviation 1.455 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 42 | -1.211 factor of ULN | Standard Deviation 1.05 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | Week 48 | -1.104 factor of ULN | Standard Deviation 1.084 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | FU Week 4 | -1.669 factor of ULN | Standard Deviation 0.95 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | FU Week 12 | -1.283 factor of ULN | Standard Deviation 1.501 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Group C | FU Week 24 | -1.256 factor of ULN | Standard Deviation 1.757 |
Secondary
Change From Baseline in Quantitative Serum ALT Level in Groups A and B
The change in quantitative ALT from Baseline to each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 1 | 0.606 factor of ULN | Standard Deviation 1.565 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 2 | 0.06 factor of ULN | Standard Deviation 2.283 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 4 | 0.564 factor of ULN | Standard Deviation 3.026 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 8 | 0.463 factor of ULN | Standard Deviation 3.225 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 12 | 0.415 factor of ULN | Standard Deviation 3.732 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 42 | -0.436 factor of ULN | Standard Deviation 2.732 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 48 | -0.63 factor of ULN | Standard Deviation 2.652 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | FU Week 4 | -1.474 factor of ULN | Standard Deviation 2.889 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | FU Week 12 | -0.736 factor of ULN | Standard Deviation 2.972 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | FU Week 24 | -1.302 factor of ULN | Standard Deviation 2.766 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 18 | 0.288 factor of ULN | Standard Deviation 3.332 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 24 | 0.004 factor of ULN | Standard Deviation 3.496 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 30 | -0.1 factor of ULN | Standard Deviation 3.163 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 36 | -0.302 factor of ULN | Standard Deviation 2.8 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 12 | 0.598 factor of ULN | Standard Deviation 5.934 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | FU Week 24 | -0.701 factor of ULN | Standard Deviation 2.22 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 36 | -0.51 factor of ULN | Standard Deviation 1.835 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 24 | -0.462 factor of ULN | Standard Deviation 2.311 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Quantitative Serum ALT Level in Groups A and B | Week 48 | -0.939 factor of ULN | Standard Deviation 1.914 |
Secondary
Change From Baseline in Weight for Age Z-Score in Group C
The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Baseline | 0.187 standard deviations | Standard Deviation 1.141 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 1 | -0.044 standard deviations | Standard Deviation 0.052 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 2 | -0.023 standard deviations | Standard Deviation 0.107 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 4 | 0.049 standard deviations | Standard Deviation 0.243 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 8 | -0.041 standard deviations | Standard Deviation 0.198 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 12 | 0.012 standard deviations | Standard Deviation 0.288 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 18 | -0.018 standard deviations | Standard Deviation 0.377 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 24 | -0.089 standard deviations | Standard Deviation 0.245 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 30 | -0.094 standard deviations | Standard Deviation 0.34 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 36 | 0 standard deviations | Standard Deviation 0.443 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 42 | -0.032 standard deviations | Standard Deviation 0.344 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | Week 48 | -0.208 standard deviations | Standard Deviation 0.374 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | FU Week 4 | -0.054 standard deviations | Standard Deviation 0.35 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | FU Week 12 | -0.156 standard deviations | Standard Deviation 0.29 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Group C | FU Week 24 | -0.161 standard deviations | Standard Deviation 0.309 |
Secondary
Change From Baseline in Weight for Age Z-Score in Groups A and B
The difference between the population mean and raw scores was calculated as the weight for age z-score. Mean absolute values at Baseline were reported. The change from Baseline to each visit was averaged among all participants and expressed in units of standard deviations.Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 1 | -0.024 standard deviations | Standard Deviation 0.089 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 4 | -0.048 standard deviations | Standard Deviation 0.158 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 8 | -0.082 standard deviations | Standard Deviation 0.228 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 12 | -0.09 standard deviations | Standard Deviation 0.267 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 42 | -0.24 standard deviations | Standard Deviation 0.375 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 48 | -0.214 standard deviations | Standard Deviation 0.371 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | FU Week 4 | -0.156 standard deviations | Standard Deviation 0.346 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | FU Week 12 | -0.089 standard deviations | Standard Deviation 0.384 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | FU Week 24 | -0.046 standard deviations | Standard Deviation 0.452 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Baseline | 0.106 standard deviations | Standard Deviation 1.154 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 2 | -0.023 standard deviations | Standard Deviation 0.108 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 18 | -0.155 standard deviations | Standard Deviation 0.309 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 24 | -0.165 standard deviations | Standard Deviation 0.35 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 30 | -0.189 standard deviations | Standard Deviation 0.372 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 36 | -0.192 standard deviations | Standard Deviation 0.395 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 12 | -0.04 standard deviations | Standard Deviation 0.241 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | FU Week 24 | -0.322 standard deviations | Standard Deviation 0.325 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | FU Week 12 | -0.263 standard deviations | Standard Deviation 0.333 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 24 | -0.09 standard deviations | Standard Deviation 0.323 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 48 | -0.082 standard deviations | Standard Deviation 0.343 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Baseline | -0.047 standard deviations | Standard Deviation 1.154 |
| Group B: Untreated Control Without Advanced Fibrosis | Change From Baseline in Weight for Age Z-Score in Groups A and B | Week 36 | -0.057 standard deviations | Standard Deviation 0.338 |
Secondary
Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category
AUC was estimated using population pharmacokinetic (PK) modeling. The AUC at steady-state was averaged among participants who received PEG-IFN and reported by BSA category. Categories of BSA-based dosing used in the analysis were as follows: 0.54-0.74 m\^2, 65 mcg; 0.75-1.08 m\^2, 90 mcg; 1.09-1.51 m\^2, 135 mcg; \>1.51 m\^2, 180 mcg. The estimated AUC was expressed in hours by nanograms per milliliter (h\*ng/mL). PK Substudy Population: All participants who consented to participate in the PK substudy. Number of subjects analyzed reflects the total combined number of participants who provided evaluable data across all BSA categories. The number of participants who provided evaluable data within each BSA category (n) is shown in the table.
Time frame: Pre-dose (0 hours) at Baseline and Weeks 4, 8, 12, 24; post-dose (24-48, 72-96, 168 hours) during Weeks 1, 24 (up to 24 weeks overall)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category | 0.54-0.74 m^2 | 3320 h*ng/mL |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category | 0.75-1.08 m^2 | 4037 h*ng/mL |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category | 1.09-1.51 m^2 | 2765 h*ng/mL |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Estimated Area Under the Concentration-Time Curve (AUC) by BSA Category | >1.51 m^2 | 3448 h*ng/mL |
Secondary
Percentage of Participants With >15% Drop in Height Percentile for Age in Group C
The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population.
Time frame: Weeks 30, 36; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | Week 30 | 20 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | Week 36 | 10 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | FU Week 4 | 10 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | FU Week 12 | 10 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Group C | FU Week 24 | 20 percentage of participants |
Secondary
Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B
The percentage of participants with \>15% drop in height percentile for age from Baseline to each visit was reported. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 12, 24, 36, 48; FU Weeks 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 12 | 1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 24 | 5 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 36 | 4 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 48 | 6.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | FU Week 12 | 10.9 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | FU Week 24 | 12 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | FU Week 12 | 4.2 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 12 | 0 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 48 | 2.1 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 24 | 8.5 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | FU Week 24 | 6.7 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Height Percentile for Age in Groups A and B | Week 36 | 4.2 percentage of participants |
Secondary
Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B
The percentage of participants with \>15% drop in weight percentile for age from Baseline to each visit was reported. Safety Population. Number of subjects analyzed reflects the total number of participants who provided evaluable data at any timepoint. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Weeks 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 18 | 8.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | FU Week 4 | 8.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | FU Week 12 | 6.9 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 24 | 16 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | FU Week 24 | 11 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 4 | 2 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 12 | 5.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 30 | 13.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 36 | 11.3 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 8 | 5 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 42 | 13.1 percentage of participants |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 48 | 12.5 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | FU Week 24 | 20 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 12 | 2.1 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 24 | 8.5 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 36 | 8.3 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | Week 48 | 8.5 percentage of participants |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With >15% Drop in Weight Percentile for Age in Groups A and B | FU Week 12 | 20.8 percentage of participants |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 22.8 percentage of participants | 95% Confidence Interval 15.02 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 4 percentage of participants | 95% Confidence Interval 0.49 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | 27.3 percentage of participants |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT in Group C | 20 percentage of participants | 95% Confidence Interval 2.52 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | 6.9 percentage of participants | 95% Confidence Interval 2.83 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | 6 percentage of participants | 95% Confidence Interval 1.25 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 19.8 percentage of participants | 95% Confidence Interval 12.54 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 2 percentage of participants | 95% Confidence Interval 0.05 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | 21.2 percentage of participants |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT in Group C | 20 percentage of participants | 95% Confidence Interval 2.52 |
Secondary
Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with combined HBeAg seroconversion and HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | 6.9 percentage of participants | 95% Confidence Interval 2.83 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Combined HBeAg Seroconversion and HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at 24 Weeks After EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With HBeAg Seroconversion at EOT in Group C
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at EOT in Group C | 20 percentage of participants | 95% Confidence Interval 2.52 |
Secondary
Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The percentage of participants with HBeAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B | 7.9 percentage of participants | 95% Confidence Interval 3.48 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion at EOT/POP in Groups A and B | 6 percentage of participants | 95% Confidence Interval 1.25 |
Secondary
Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B
HBeAg seroconversion was defined as loss of HBeAg and the presence of anti-HBe. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Baseline, FU Years: 1, 2, 3, 4, 5
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 2 | 33.7 percentage of subjects | 95% Confidence Interval 24.56 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Baseline | 0.00 percentage of subjects | 95% Confidence Interval 0 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 1 | 32.7 percentage of subjects | 95% Confidence Interval 23.67 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 3 | 46.5 percentage of subjects | 95% Confidence Interval 36.55 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 4 | 30.7 percentage of subjects | 95% Confidence Interval 21.9 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 5 | 5.9 percentage of subjects | 95% Confidence Interval 2.21 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 4 | 8.00 percentage of subjects | 95% Confidence Interval 2.22 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 3 | 6.08 percentage of subjects | 95% Confidence Interval 1.25 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Baseline | 0.00 percentage of subjects | 95% Confidence Interval 0 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 5 | 0.00 percentage of subjects | 95% Confidence Interval 0 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 1 | 6.08 percentage of subjects | 95% Confidence Interval 1.25 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBeAg Seroconversion Over Time in Groups A and B | Fu Year 2 | 6.08 percentage of subjects | 95% Confidence Interval 1.25 |
Secondary
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBsAg Seroconversion at 24 Weeks After EOT in Group C | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBsAg Seroconversion at 24 Weeks After the End of Switch Treatment Period: Switch Group | 9.1 percentage of participants |
Secondary
Percentage of Participants With HBsAg Seroconversion at EOT in Group C
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBsAg Seroconversion at EOT in Group C | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B
HBsAg seroconversion was defined as loss of HBsAg and the presence of anti-HBs. The percentage of participants with HBsAg seroconversion at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B | 6.9 percentage of participants | 95% Confidence Interval 2.83 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBsAg Seroconversion at EOT/POP in Groups A and B | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B
HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B | 33.7 percentage of participants | 95% Confidence Interval 24.56 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After EOT/POP in Groups A and B | 4 percentage of participants | 95% Confidence Interval 0.49 |
Secondary
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBV DNA was quantified using polymerase chain reaction (PCR) by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) <20,000 International Units Per Milliliter (IU/mL) at 24 Weeks After the End of Switch Treatment Period: Switch Group | 36.4 percentage of participants |
Secondary
Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <20,000 IU/mL at 24 Weeks After EOT in Group C | 70 percentage of participants | 95% Confidence Interval 34.75 |
Secondary
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <20,000 IU/mL at EOT in Group C | 40 percentage of participants | 95% Confidence Interval 12.16 |
Secondary
Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<20,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | 36.6 percentage of participants | 95% Confidence Interval 27.27 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBV DNA <20,000 IU/mL at EOT/POP in Groups A and B | 12 percentage of participants | 95% Confidence Interval 4.53 |
Secondary
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT in Group C | 70 percentage of participants | 95% Confidence Interval 34.75 |
Secondary
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 28.7 percentage of participants | 95% Confidence Interval 20.15 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After EOT/POP in Groups A and B | 2 percentage of participants | 95% Confidence Interval 0.05 |
Secondary
Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at 24 Weeks After the End of Switch Treatment Period: Switch Group | 27.3 percentage of participants |
Secondary
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B
HBV DNA was quantified using PCR by Roche Taqman. The percentage of participants with HBV DNA \<2,000 IU/mL at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | 30.7 percentage of participants | 95% Confidence Interval 21.9 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBV DNA <2,000 IU/mL at EOT/POP in Groups A and B | 2 percentage of participants | 95% Confidence Interval 0.05 |
Secondary
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA Undetectable at 24 Weeks After EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA Undetectable at 24 Weeks After the End of Switch Treatment Period: Switch Group | 18.2 percentage of participants |
Secondary
Percentage of Participants With HBV DNA Undetectable at EOT in Group C
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA Undetectable at EOT in Group C | 20 percentage of participants | 95% Confidence Interval 2.52 |
Secondary
Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B
HBV DNA was quantified using PCR by Roche Taqman. Undetectable HBV DNA was defined as HBV DNA \<29 IU/mL. The percentage of participants with HBV DNA undetectable at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B | 18.8 percentage of participants | 95% Confidence Interval 11.72 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With HBV DNA Undetectable at EOT/POP in Groups A and B | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B
HBsAg seroconversion was defined as loss of HBsAg and the presence of hepatitis B surface antibody (anti-HBs). The percentage of participants with HBsAg seroconversion at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B | 7.9 percentage of participants | 95% Confidence Interval 3.48 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion at 24 Weeks After EOT/POP in Groups A and B | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C
The percentage of participants with loss of HBeAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population: All participants who received at least one dose of study drug (if assigned) and had at least one post-baseline safety assessment.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT in Group C | 30 percentage of participants | 95% Confidence Interval 6.67 |
Secondary
Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B
The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B | 25.7 percentage of participants | 95% Confidence Interval 17.56 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at 24 Weeks After EOT/POP in Groups A and B | 6 percentage of participants | 95% Confidence Interval 1.25 |
Secondary
Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group
The percentage of participants with loss of HBeAg at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at 24 Weeks After the End of Switch Treatment Period: Switch Group | 30.3 percentage of participants |
Secondary
Percentage of Participants With Loss of HBeAg at EOT in Group C
The percentage of participants with loss of HBeAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at EOT in Group C | 20 percentage of participants | 95% Confidence Interval 2.52 |
Secondary
Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B
The percentage of participants with loss of HBeAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B | 8.9 percentage of participants | 95% Confidence Interval 4.16 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Loss of HBeAg at EOT/POP in Groups A and B | 6 percentage of participants | 95% Confidence Interval 1.25 |
Secondary
Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C
The percentage of participants with loss of HBsAg at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBsAg at 24 Weeks After EOT in Group C | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBsAg at 24 Weeks After the End of Switch Treatment Period: Switch Group | 12.1 percentage of participants |
Secondary
Percentage of Participants With Loss of HBsAg at EOT in Group C
The percentage of participants with loss of HBsAg at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBsAg at EOT in Group C | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B
The percentage of participants with loss of HBsAg at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B | 10.9 percentage of participants | 95% Confidence Interval 5.56 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Loss of HBsAg at EOT/POP in Groups A and B | 0 percentage of participants | 95% Confidence Interval 0 |
Secondary
Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C
Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Normal ALT at 24 Weeks After EOT in Group C | 70 percentage of participants | 95% Confidence Interval 34.75 |
Secondary
Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B
Normal ALT was defined as ALT less than or equal to (≤) ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at 24 weeks after EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B | 51.5 percentage of participants | 95% Confidence Interval 41.33 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Normal ALT at 24 Weeks After EOT/POP in Groups A and B | 12 percentage of participants | 95% Confidence Interval 4.53 |
Secondary
Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group
Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Normal ALT at 24 Weeks After the End of Switch Treatment Period: Switch Group | 42.4 percentage of participants |
Secondary
Percentage of Participants With Normal ALT at EOT in Group C
Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT was reported. The 95% CI was calculated by the Pearson-Clopper method. Safety Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Normal ALT at EOT in Group C | 40 percentage of participants | 95% Confidence Interval 12.16 |
Secondary
Percentage of Participants With Normal ALT at EOT/POP in Groups A and B
Normal ALT was defined as ALT ≤ ULN, where each ULN was given by the laboratory at which the sample was analyzed. The percentage of participants with normal ALT at EOT/POP was reported. The 95% CI was calculated by the Pearson-Clopper method. ITT Population.
Time frame: Week 48
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Percentage of Participants With Normal ALT at EOT/POP in Groups A and B | 18.8 percentage of participants | 95% Confidence Interval 11.72 |
| Group B: Untreated Control Without Advanced Fibrosis | Percentage of Participants With Normal ALT at EOT/POP in Groups A and B | 22 percentage of participants | 95% Confidence Interval 11.53 |
Secondary
Quantitative HBeAg Level in Group C
Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 PEIU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | Baseline | 2.344 log10 PEIU/mL | Standard Deviation 0.981 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | Week 12 | 1.62 log10 PEIU/mL | Standard Deviation 1.288 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | Week 24 | 1.802 log10 PEIU/mL | Standard Deviation 1.14 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | Week 36 | 1.561 log10 PEIU/mL | Standard Deviation 1.178 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | Week 48 | 1.429 log10 PEIU/mL | Standard Deviation 1.259 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Group C | FU Week 24 | 1.442 log10 PEIU/mL | Standard Deviation 1.416 |
Secondary
Quantitative HBeAg Level in Groups A and B
Quantitative HBeAg at each visit was averaged among all participants and expressed in log10 Paul Ehrlich Institute units per milliliter (PEIU/mL). ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Baseline | 2.736 log10 PEIU/mL | Standard Deviation 0.502 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 12 | 2.09 log10 PEIU/mL | Standard Deviation 0.879 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 24 | 1.865 log10 PEIU/mL | Standard Deviation 0.956 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 36 | 1.604 log10 PEIU/mL | Standard Deviation 0.991 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 48 | 1.466 log10 PEIU/mL | Standard Deviation 1.053 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | FU Week 24 | 1.537 log10 PEIU/mL | Standard Deviation 1.334 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 48 | 2.124 log10 PEIU/mL | Standard Deviation 1.091 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Baseline | 2.568 log10 PEIU/mL | Standard Deviation 0.65 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 36 | 2.272 log10 PEIU/mL | Standard Deviation 0.985 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 12 | 2.391 log10 PEIU/mL | Standard Deviation 0.878 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | FU Week 24 | 2.217 log10 PEIU/mL | Standard Deviation 1.395 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBeAg Level in Groups A and B | Week 24 | 2.36 log10 PEIU/mL | Standard Deviation 0.896 |
Secondary
Quantitative HBsAg Level in Group C
Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | Baseline | 4.225 log10 IU/mL | Standard Deviation 0.518 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | Week 12 | 3.829 log10 IU/mL | Standard Deviation 0.589 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | Week 24 | 3.515 log10 IU/mL | Standard Deviation 1.113 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | Week 36 | 3.282 log10 IU/mL | Standard Deviation 1.263 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | Week 48 | 3.215 log10 IU/mL | Standard Deviation 1.352 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Group C | FU Week 24 | 3.137 log10 IU/mL | Standard Deviation 1.463 |
Secondary
Quantitative HBsAg Level in Groups A and B
Quantitative HBsAg at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. All participants were included in the endpoint analysis. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Week 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Baseline | 4.309 log10 IU/mL | Standard Deviation 0.687 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 12 | 3.844 log10 IU/mL | Standard Deviation 1.186 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 24 | 3.509 log10 IU/mL | Standard Deviation 1.507 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 36 | 3.265 log10 IU/mL | Standard Deviation 1.661 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 48 | 3.078 log10 IU/mL | Standard Deviation 1.769 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | FU Week 24 | 3.37 log10 IU/mL | Standard Deviation 1.63 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 48 | 4.215 log10 IU/mL | Standard Deviation 0.718 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Baseline | 4.383 log10 IU/mL | Standard Deviation 0.721 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 36 | 4.272 log10 IU/mL | Standard Deviation 0.726 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 12 | 4.299 log10 IU/mL | Standard Deviation 0.809 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | FU Week 24 | 4.394 log10 IU/mL | Standard Deviation 0.939 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBsAg Level in Groups A and B | Week 24 | 4.336 log10 IU/mL | Standard Deviation 0.732 |
Secondary
Quantitative HBV DNA Level in Group C
Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | Baseline | 7.866 log10 IU/mL | Standard Deviation 0.977 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | Week 12 | 5.782 log10 IU/mL | Standard Deviation 1.771 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | Week 24 | 5.599 log10 IU/mL | Standard Deviation 2.386 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | Week 36 | 5.2 log10 IU/mL | Standard Deviation 2.451 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | Week 48 | 5.319 log10 IU/mL | Standard Deviation 2.747 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | FU Week 4 | 4.604 log10 IU/mL | Standard Deviation 2.442 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | FU Week 12 | 4.252 log10 IU/mL | Standard Deviation 2.596 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Group C | FU Week 24 | 3.694 log10 IU/mL | Standard Deviation 3.127 |
Secondary
Quantitative HBV DNA Level in Groups A and B
Quantitative HBV DNA at each visit was averaged among all participants and expressed in log10 IU/mL. ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 12, 24, 36, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | FU Week 24 | 5.707 log10 IU/mL | Standard Deviation 3.113 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Baseline | 8.094 log10 IU/mL | Standard Deviation 0.986 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 12 | 6.49 log10 IU/mL | Standard Deviation 2.009 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 24 | 5.966 log10 IU/mL | Standard Deviation 2.398 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 36 | 5.575 log10 IU/mL | Standard Deviation 2.513 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 48 | 5.224 log10 IU/mL | Standard Deviation 2.701 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | FU Week 4 | 5.739 log10 IU/mL | Standard Deviation 2.935 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | FU Week 12 | 5.914 log10 IU/mL | Standard Deviation 3.065 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 36 | 7.685 log10 IU/mL | Standard Deviation 1.608 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Baseline | 8.056 log10 IU/mL | Standard Deviation 0.987 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | FU Week 24 | 7.2 log10 IU/mL | Standard Deviation 2.506 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 12 | 7.909 log10 IU/mL | Standard Deviation 1.267 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 48 | 7.551 log10 IU/mL | Standard Deviation 1.761 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | Week 24 | 7.857 log10 IU/mL | Standard Deviation 1.327 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative HBV DNA Level in Groups A and B | FU Week 12 | 7.214 log10 IU/mL | Standard Deviation 2.46 |
Secondary
Quantitative Serum ALT Level in Group C
Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). Safety Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Baseline | 2.804 factor of ULN | Standard Deviation 1.118 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 1 | 3.117 factor of ULN | Standard Deviation 1.322 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 2 | 2.896 factor of ULN | Standard Deviation 1.304 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 4 | 2.444 factor of ULN | Standard Deviation 1.727 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 8 | 2.703 factor of ULN | Standard Deviation 2.035 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 12 | 2.793 factor of ULN | Standard Deviation 1.288 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 18 | 2.215 factor of ULN | Standard Deviation 1.032 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 24 | 1.887 factor of ULN | Standard Deviation 1.095 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 30 | 2.22 factor of ULN | Standard Deviation 1.553 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 36 | 2.172 factor of ULN | Standard Deviation 1.09 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 42 | 1.593 factor of ULN | Standard Deviation 0.516 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | Week 48 | 1.645 factor of ULN | Standard Deviation 1.242 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | FU Week 4 | 1.136 factor of ULN | Standard Deviation 0.506 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | FU Week 12 | 1.521 factor of ULN | Standard Deviation 0.755 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Group C | FU Week 24 | 1.549 factor of ULN | Standard Deviation 1.595 |
Secondary
Quantitative Serum ALT Level in Groups A and B
Quantitative ALT at each visit was averaged among all participants and expressed as a factor of the laboratory-specific ULN (for example, 1 × ULN, 2 × ULN, 3 × ULN). ITT Population. The number of participants who provided evaluable data for the analysis at each timepoint (n) is shown in the table.
Time frame: Baseline; Weeks 1, 2, 4, 8, 12, 18, 24, 30, 36, 42, 48; FU Weeks 4, 12, 24 (up to 72 weeks overall)
Population: If number of participants equals 0, the calculation was not performed because no participants provided data for the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 2 | 2.846 factor of ULN | Standard Deviation 1.885 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | FU Week 4 | 1.303 factor of ULN | Standard Deviation 1.74 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | FU Week 12 | 2.064 factor of ULN | Standard Deviation 2.027 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | FU Week 24 | 1.477 factor of ULN | Standard Deviation 1.625 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 36 | 2.45 factor of ULN | Standard Deviation 1.856 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 4 | 3.343 factor of ULN | Standard Deviation 2.455 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 8 | 3.262 factor of ULN | Standard Deviation 2.797 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 12 | 3.189 factor of ULN | Standard Deviation 3.06 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 18 | 3.036 factor of ULN | Standard Deviation 2.389 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 24 | 2.753 factor of ULN | Standard Deviation 2.725 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Baseline | 2.779 factor of ULN | Standard Deviation 2.483 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 30 | 2.587 factor of ULN | Standard Deviation 2.128 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 1 | 3.427 factor of ULN | Standard Deviation 2.687 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 42 | 2.316 factor of ULN | Standard Deviation 1.429 |
| Group A: PEG-IFN Monotherapy Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 48 | 2.122 factor of ULN | Standard Deviation 1.389 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | FU Week 24 | 1.7 factor of ULN | Standard Deviation 1.385 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Baseline | 2.878 factor of ULN | Standard Deviation 1.997 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 24 | 2.401 factor of ULN | Standard Deviation 2.638 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 36 | 2.341 factor of ULN | Standard Deviation 2.204 |
| Group B: Untreated Control Without Advanced Fibrosis | Quantitative Serum ALT Level in Groups A and B | Week 48 | 1.954 factor of ULN | Standard Deviation 1.371 |