Hepatitis B, Chronic
Conditions
Brief summary
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B. Patients will be randomized to one of 4 treatment groups: a)PEGASYS 90 micrograms subcutaneous (sc) weekly for 24 weeks, b)PEGASYS 180 micrograms sc weekly for 24 weeks, c)PEGASYS 90 micrograms sc weekly for 48 weeks or d)PEGASYS 180 micrograms sc weekly for 48 weeks. Following treatment there will be a 24 week period of treatment-free follow-up in all treatment groups for the primary endpoint. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Interventions
DRUGpeginterferon alfa-2a [Pegasys]
90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * positive Hepatitis B surface antigen (HBsAg) for \>6 months, positive HBeAg, HBV DNA \>500,000 copies/mL, and anti-HBs negative; * liver disease consistent with Chronic Hepatitis B.
Exclusion criteria
* antiviral therapy for CHB within previous 6 months; * co-infection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV) or Human immuno deficiency virus (HIV); * evidence of decompensated liver disease; * medical condition associated with chronic liver disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | Week 72 | Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72. |
| Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg. |
| Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment. |
| Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg. |
| Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay. |
| Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported. |
| Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment) | Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported. |
| Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL. |
| Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL). |
| Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L). |
| Quantitative HBV-DNA 24 Weeks Following End of Treatment | 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment) | Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. |
Countries
Australia, Brazil, China, France, Germany, Hong Kong, New Zealand, Russia, Singapore, South Korea, Taiwan, Thailand, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. | 140 |
| Peginterferon Alfa-2a 180 μg_24 Weeks Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. | 136 |
| Peginterferon Alfa-2a 90 μg_48 Weeks Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. | 136 |
| Peginterferon Alfa-2a 180 μg_48 Weeks Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. | 136 |
| Total | 548 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Abnormality of Laboratory Test | 0 | 1 | 0 | 0 |
| Overall Study | Did not complete full follow-up period | 6 | 6 | 4 | 5 |
| Overall Study | Did not enter follow-up | 0 | 4 | 1 | 3 |
| Overall Study | Did not receive study drug | 1 | 0 | 2 | 0 |
| Overall Study | Failure to return | 5 | 0 | 4 | 0 |
| Overall Study | Insufficient Therapeutic Response | 3 | 1 | 0 | 3 |
| Overall Study | Other Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Refused treatment | 2 | 0 | 0 | 5 |
Baseline characteristics
| Characteristic | Peginterferon Alfa-2a 90 μg_48 Weeks | Peginterferon Alfa-2a 180 μg_48 Weeks | Total | Peginterferon Alfa-2a 90 μg_24 Weeks | Peginterferon Alfa-2a 180 μg_24 Weeks |
|---|---|---|---|---|---|
| Age, Customized | 33.8 Years FULL_RANGE 10.48 | 33.3 Years FULL_RANGE 10.89 | 32.98 Years | 31.8 Years FULL_RANGE 9.77 | 33.0 Years FULL_RANGE 10.52 |
| Sex: Female, Male Female | 40 Participants | 48 Participants | 171 Participants | 44 Participants | 39 Participants |
| Sex: Female, Male Male | 96 Participants | 88 Participants | 377 Participants | 96 Participants | 97 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 94 / 144 | 109 / 141 | 92 / 132 | 105 / 130 |
| serious Total, serious adverse events | 4 / 144 | 4 / 141 | 6 / 132 | 5 / 130 |
Outcome results
Primary
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment
Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBe) determined at 24 weeks after the end of treatment.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 14.08 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 22.86 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 25.76 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion 24 Weeks Following End of Treatment | 36.15 Percentage of participants |
Secondary
Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment
Combined endpoint was defined as HBeAg seroconversion, a normal serum ALT and HBV-DNA suppression below 20,000 IU/mL.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 7.75 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 15.0 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 17.42 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Combined Endpoint Response 24 Weeks Following End of Treatment | 31.54 Percentage of participants |
Secondary
Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment
Dual endpoint was defined as the achievement of both HBeAg seroconversion and a HBV-DNA \<2,000 IU/ml (Less than 10,000 copies/mL).
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 7.75 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 9.29 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 13.64 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Dual Endpoint Response 24 Weeks Following End of Treatment | 24.62 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72
Blood was collected for HBeAg. HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of anti-HBe (a positive result for anti-HBs) determined at Week 72.
Time frame: Week 72
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | 18.31 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | 27.14 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | 25.76 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Hepatitis Be Antigen (HBeAg) Seroconversion at Week 72 | 36.15 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment
HBsAg seroconversion was defined as the absence of HBsAg (a negative result for HBsAg) and the presence of anti-HBs (a positive result for anti-HBs) determined at 24 weeks after the end of treatment.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 0.0 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 0.0 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 1.52 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroconversion 24 Weeks Following the End of Treatment | 2.31 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment
Blood was collected for HBV-DNA 24 weeks following the end of treatment and was analyzed at the central laboratory using the Roche approved polymerase chain reaction (PCR) methodology. Percentage of participants with a HBV-DNA suppression of \< 20,000 IU/mL (Less than 100,000 copies/mL) is reported.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 21.83 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 21.43 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 32.58 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Suppression < 20,000 IU/mL 24 Weeks Following End of Treatment | 42.31 Percentage of participants |
Secondary
Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment
Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment. Percentage of participants with A HBV-DNA Suppression of \< 2,000 IU/mL (Less than 10,000 copies/mL) is reported.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment of Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 11.27 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 11.43 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 22.73 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Hepatitis Deoxyribonucleic Acid (HBV-DNA) Suppression < 2,000 IU/mL 24 Weeks Following End of Treatment | 30.0 Percentage of participants |
Secondary
Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment
Blood was collected HBeAg 24 Weeks following the end of treatment. Loss of HBeAg is defined as the absence of HBeAg.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the Per protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 14.79 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 22.86 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 26.52 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Loss of Hepatitis Be Antigen (HBeAg) 24 Weeks Following End of Treatment | 36.15 Percentage of participants |
Secondary
Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment
Blood was collected for HBsAg 24 weeks following the end of treatment. Loss of HBsAg is defined as the absence of HBsAg.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 0.70 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 0.0 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 2.27 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Loss of Hepatitis B Surface Antigen (HBsAg) 24 Weeks Following End of Treatment | 2.31 Percentage of participants |
Secondary
Percentage of Participants With Normal Alanine Aminotransferase (ALT)
Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation. Patients were analyzed according to the treatment received, rather than the randomized treatment. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 30.28 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 30.71 Percentage of participants |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 43.18 Percentage of participants |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Percentage of Participants With Normal Alanine Aminotransferase (ALT) | 52.31 Percentage of participants |
Secondary
Quantitative HBV-DNA 24 Weeks Following End of Treatment
Blood was collected for HBV-DNA and was analyzed at the central laboratories using the Roche approved PCR methodology 24 weeks following the end of treatment.
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Quantitative HBV-DNA 24 Weeks Following End of Treatment | 6.33 IU/mL Log10 |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Quantitative HBV-DNA 24 Weeks Following End of Treatment | 6.38 IU/mL Log10 |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Quantitative HBV-DNA 24 Weeks Following End of Treatment | 5.98 IU/mL Log10 |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Quantitative HBV-DNA 24 Weeks Following End of Treatment | 5.29 IU/mL Log10 |
Secondary
Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment
Blood was collected 24 weeks following the end of treatment for ALT and was analyzed at a local laboratory. A normal ALT is a value within the normal range of the assay: 0- 55 units/liter (U/L).
Time frame: 24 Weeks following end of treatment (Week 48 for 24 Week Treatment or Week 72 for 48 Week Treatment)
Population: Participants from the Per-protocol population defined as all participants who received study drug and who did not have any major protocol deviation who had data available for analysis. Patients were analyzed according to the treatment received. 10 patients in the per-protocol population switched treatment groups for the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Peginterferon Alfa-2a 90 μg_24 Weeks | Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | 1.90 U/L |
| Peginterferon Alfa-2a 180 μg_24 Weeks | Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | 1.97 U/L |
| Peginterferon Alfa-2a 90 μg_48 Weeks | Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | 1.90 U/L |
| Peginterferon Alfa-2a 180 μg_48 Weeks | Quantitative Serum Alanine Aminotransferase (ALT) 24 Weeks Following End of Treatment | 1.73 U/L |