A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
Phase 4
Withdrawn
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT01179594
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \<500 patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- adult patients, >/= 18 years of age
- chronic hepatitis B for >/= 6 months
- HBeAg negative at screening
- adequate renal function
Exclusion Criteria
- antiviral therapy for chronic hepatitis B within the previous 6 months
- hepatitis A, C, D or HIV infection
- treatment with systemic acyclovir or famciclovir within the previous 6 months
- decompensated liver disease (Childs B-C)
- history or evidence of a medical condition associated with chronic liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A peginterferon alfa-2a [Pegasys] - C placebo - D peginterferon alfa-2a [Pegasys] - A placebo - C peginterferon alfa-2a [Pegasys] - B peginterferon alfa-2a [Pegasys] - D entecavir - B entecavir -
- Primary Outcome Measures
Name Time Method Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml) 48 weeks after the end of treatment
- Secondary Outcome Measures
Name Time Method Correlation early HBsAg response - response end of treatment/follow-up every 6 weeks up to week 48, every 12 weeks therafter