Conditions: Hepatitis B, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 551
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks. arm 2: Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks. arm 3: Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks. arm 4: Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.

Interventions: intervention 1: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 90 or 180 micrograms subcutaneous weekly for 24 weeks or 48 weeks.

Protocol document: