Hepatitis B, Chronic
Conditions
Brief summary
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past. All patients will receive PEGASYS, 180 micrograms s.c. weekly for 48 weeks, followed by 48 weeks of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* adult patients, 18-70 years of age; * chronic hepatitis B; * Hepatitis B Virus (HBV) DNA \>100,000 copies/mL.
Exclusion criteria
* previous antiviral or interferon-based therapy for chronic hepatitis B in past 6 months; * evidence of decompensated liver disease; * history or evidence of a medical condition associated with chronic liver disease other than viral hepatitis; * coinfection with hepatitis A, C or D, or HIV.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL | Week 96 | This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) \<100,000 copies/mL were reported. |
| Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL | Week 96 | This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | Week 96 | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants. |
| Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | Week 96 | Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants. |
| Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | Up to Week 96 | All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported. |
| Mean Change in Laboratory Parameters (ALT Levels) | From Screening (Day 0) to Week 96 | Mean Change in Laboratory parameters (ALT levels) is reported. |
Countries
Russia
Participant flow
Recruitment details
The study was conducted at 7 centers in Russia.
Pre-assignment details
Out of 20 participants, 18 were included in the study. (4 were Hepatitis B Early Antigen \[HBeAg\] positive and 14 were HBeAg-negative).
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a Eligible participants were administered peginterferon alfa-2a, 180 microgram (mcg) subcutaneous (SC) once weekly for 48 weeks and were followed for next 48 weeks. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 9 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| HBeAg-negative participants | 14 Participants |
| Hepatitis B Early Antigen (HBeAg) positive participants | 4 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL
This study included 14 HBeAg negative participants. Participants with HBV DNA \<20,000 copies/mL were reported.
Time frame: Week 96
Population: All participants who received at least one dose of the study drug were considered for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of HBeAg Negative Participants With HBV DNA < 20,000 Copies Per mL | 3 Participants |
Primary
Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL
This study included four Hepatitis B Early Antigen (HBeAg) positive participants. Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) \<100,000 copies/mL were reported.
Time frame: Week 96
Population: All participants who received at least one dose of the study drug were considered for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a | Number of HBeAg Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid <100,000 Copies Per mL | 4 Participants |
Secondary
Mean Change in Laboratory Parameters (ALT Levels)
Mean Change in Laboratory parameters (ALT levels) is reported.
Time frame: From Screening (Day 0) to Week 96
Population: Safety population included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 1) | 92.9 International units per liter (IU/L) | Standard Deviation 73.2 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 2) | 97.2 International units per liter (IU/L) | Standard Deviation 89.9 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 4) | 109.4 International units per liter (IU/L) | Standard Deviation 133.6 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 8) | 81.2 International units per liter (IU/L) | Standard Deviation 105.4 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT Week 12) | 65.1 International units per liter (IU/L) | Standard Deviation 35.9 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 18) | 53.3 International units per liter (IU/L) | Standard Deviation 26.2 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 24) | 66.2 International units per liter (IU/L) | Standard Deviation 32.3 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 32) | 55 International units per liter (IU/L) | Standard Deviation 30.2 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 40) | 46 International units per liter (IU/L) | Standard Deviation 17.6 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 48) | 38.4 International units per liter (IU/L) | Standard Deviation 18.4 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 52) | 37.1 International units per liter (IU/L) | Standard Deviation 5.1 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 60) | 40.5 International units per liter (IU/L) | Standard Deviation 15.1 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 72) | 36.9 International units per liter (IU/L) | Standard Deviation 4.5 |
| Peginterferon Alfa-2a | Mean Change in Laboratory Parameters (ALT Levels) | ALT (Week 96) | 32.8 International units per liter (IU/L) | Standard Deviation 8.1 |
Secondary
Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of HBsAb. This study included 14 HBeAg negative participants.
Time frame: Week 96
Population: All participants who received at least one dose of the study drug were considered for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | HBsAg seroconversion | 2 Participants |
| Peginterferon Alfa-2a | Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | ALT normalization | 3 Participants |
| Peginterferon Alfa-2a | Number of HBeAg Negative Participants With HBV DNA <400 Copies/mL, HbsAg Seroconversion and Normalization of ALT | HBV DNA <400 copies/mL | 3 Participants |
Secondary
Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion
Hepatitis B Surface Antigen (HBsAg) seroconversion is defined as a decrease in HBsAg to undetectable levels and a gain of detectable levels of Hepatitis B surface antibody (HBsAb). Sustained HBe seroconversion is defined as loss of HBeAg and presence of hepatitis B e-antibody (HBeAb). This study included 4 HBeAg positive participants.
Time frame: Week 96
Population: All participants who received at least one dose of the study drug were considered for analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | HBV DNA <400 copies/mL | 4 Participants |
| Peginterferon Alfa-2a | Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | HBsAg seroconversion | 0 Participants |
| Peginterferon Alfa-2a | Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | ALT normalization | 4 Participants |
| Peginterferon Alfa-2a | Number of HBeAg Positive Participants With HBV DNA <400 Copies Per mL, HBsAg Seroconversion, Normalization of ALT, and Sustained HBe Seroconversion | Sustained HBe seroconversion | 4 Participants |
Secondary
Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs)
All participants who received at least one dose of the study drug were analysed. Number of participants with any adverse events and any serious adverse events are reported.
Time frame: Up to Week 96
Population: Safety population included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Peginterferon Alfa-2a | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | Any AEs | 3 Participants |
| Peginterferon Alfa-2a | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |