Conditions: Hepatitis B, Chronic
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 200
Healthy volunteers: no

Brief summary:
This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms:
arm 1: Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks. arm 2: Participants received entecavir 0.5 mg orally once daily for 48 weeks.

Interventions: intervention 1: entecavir intervention 2: entecavir intervention 3: peginterferon alfa-2a [Pegasys]
Intervention descriptions: intervention 1: 0.5mg po daily for 8 weeks intervention 2: 0.5mg po daily for 48 weeks intervention 3: 180 micrograms sc/week for 48 weeks

Protocol document: