NCT00460850终止4 期
An Open Label Study to Evaluate the Effect of PEGASYS on ALT and HBV DNA Levels in Patients With Lamivudine-Resistant HbeAg-Negative Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 60
- 主要终点
- Normalization of ALT, and HBV-DNA <10,000 copies/mL
研究概览
简要总结
This single arm study will evaluate the efficacy and safety of PEGASYS in patients with lamivudine resistant HBeAg negative chronic hepatitis B. Patients will receive PEGASYS 180 micrograms s.c. weekly for 48 weeks; following this, there will be a 48 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-65 years of age;
- •HBeAg negative chronic hepatitis B;
- •treated with lamivudine for >=6 months;
- •demonstrated lamivudine resistance;
- •compensated liver disease.
排除标准
- •severe hepatic dysfunction;
- •previous treatment with antivirals other than lamivudine;
- •immunosuppressant treatment in past 6 months;
- •co-infection with hepatitis A, C, or D virus or human immunodeficiency virus;
- •medical condition associated with chronic liver disease.
研究组 & 干预措施
1
Experimental
干预措施: peginterferon alfa-2a (40KD) [PEGASYS] (Drug)
结局指标
主要结局
Normalization of ALT, and HBV-DNA <10,000 copies/mL
时间窗: Week 96
次要结局
- Normalization of ALT, and HBV-DNA <10,000 copies/mL(Weeks 48 and 72)
- HBsAg loss and anti-HBs seroconversion(Weeks 48, 72 and 96)
- AEs and lab parameters(Throughout study)
研究者
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