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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
0.5 mg orally daily, 24 weeks (weeks 12-36)
180 mcg sc weekly, 48 weeks
180 mcg sc weekly, 96 weeks
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
Time frame: 48 weeks after the end of treatment
Correlation early HBsAg response - response end of treatment/follow-up
Time frame: every 6 weeks up to week 48, every 12 weeks therafter
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orally daily, 24 weeks (weeks 12-36)