A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, >/= 18 years of age
- •chronic hepatitis B for >/= 6 months
- •HBeAg negative at screening
- •adequate renal function
排除标准
- •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
研究组 & 干预措施
A
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
A
干预措施: placebo (Drug)
B
干预措施: entecavir (Drug)
B
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
C
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
C
干预措施: placebo (Drug)
D
干预措施: entecavir (Drug)
D
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Efficacy: HBV-DNA reduction to <10,000 copies/ml (<2,000 IU/ml)
时间窗: 48 weeks after the end of treatment
次要结局
- Correlation early HBsAg response - response end of treatment/follow-up(every 6 weeks up to week 48, every 12 weeks therafter)