Conditions: Hepatitis B, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 150
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of PEGASYS (peginterferon alfa-2a) in patients with HBeAg positive chronic hepatitis B. Patients will be stratified into group A (treatment naïve patients) or B (YMDD mutant patients). All patients will receive PEGASYS 180 micrograms subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow up.

Detailed description:

Arms:
arm 1: Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up. arm 2: Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.

Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks

Protocol document: