A Randomized, Open Label Study to Compare the Effect of Combination Treatment With PEGASYS + Adefovir Dipivoxil Versus PEGASYS Monotherapy on HBV-DNA and ALT Levels in Patients With HBeAg-negative, Chronic Hepatitis B.'
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Normalization of ALT, and HBV-DNA <400 copies/mL
研究概览
简要总结
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by ADV 10mg po monotherapy for an additional 48 weeks, and a further 48 week treatment-free follow-up, 2)PEGASYS 180 micrograms sc weekly + ADV 10mg po daily for 48 weeks, followed by a 96 week treatment-free follow-up, or 3)PEGASYS 180 micrograms sc monotherapy weekly for 48 weeks, followed by a 96 week treatment-free follow-up. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-70 years of age;
- •chronic hepatitis B;
- •positive HBsAg, positive anti-HBe, negative anti HBsAg, negative HBeAg for at least the prior 6 months;
- •either nucleoside analogue naive, or has not received IFN-a in the past 6 months.
排除标准
- •positive for hepatitis A, C, D or HIV;
- •history or other evidence of a medical condition associated with chronic liver disease other than hepatitis B;
- •antiviral, antineoplastic or immunomodulatory treatment <=6 months prior to first dose of randomized treatment.
研究组 & 干预措施
1
干预措施: adefovir dipivoxil (Drug)
1
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
2
干预措施: adefovir dipivoxil (Drug)
2
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
3
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Normalization of ALT, and HBV-DNA <400 copies/mL
时间窗: Week 96 for arm 1; week 48 for arms 2 and 3
HBsAg quantitative loss and anti-HBs seroconversion
时间窗: Weeks 48, 96 and 144
次要结局
- AEs, lab parameters, vital signs(Throughtout study)