An Open-Label, Multi-Center Study Evaluating the Effect on Viral Activity and the Safety and Tolerability of Extended Treatment of Pegasys® (Peginterferon Alfa 2a ) in Combination With Copegus® (Ribavirin) in Genotype 1, 2 and 3 Chronic Hepatitis C Patients Defined as Slow Responders/Non-RVR
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 20
- 主要终点
- End of Treatment Response Rate at Week 72 in Genotype 1
研究概览
简要总结
This open-label, multi-center study will evaluate the safety and tolerability and the effect on viral activity of a combined PEGASYS and COPEGUS extended therapy in patients with chronic hepatitis C with genotype 1, 2 and 3. Patients who completed 48 weeks (genotype 1) or 24 weeks (genotype 2 and 3) of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders will be enrolled in this study in order to receive additional 24 weeks of treatment. PEGASYS 180 micrograms will be administered sc once weekly and COPEGUS will be administered as 800 mg, or 1000-1200 mg daily oral doses. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.
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 —（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 C, genotype 1, 2, 3
- •Compensated liver disease
- •Patients who completed 48 weeks or 24 weeks of standard treatment with PEGASYS and COPEGUS and were identified as slow virological responders
排除标准
- •Decompensated liver disease
- •Signs or symptoms of hepatocellular carcinoma
- •Uncontrolled hypoglycaemia, hyperglycaemia and diabetes mellitus
研究组 & 干预措施
Single arm
干预措施: COPEGUS (Drug)
Single arm
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
End of Treatment Response Rate at Week 72 in Genotype 1
时间窗: Week 72
End of treatment response rate at Week 72 was reported for genotype 1.
End of Treatment Response in Genotype 2 and 3
时间窗: Week 48
End of treatment response rate at Week 48 was reported for genotype 2 and 3.
Sustained Viral Response (SVR) Rates in CHC Genotype 1
时间窗: Week 96
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 1.
SVR Rates in Genotype 2 and 3.
时间窗: Week 72
Sustained Viral Response, undetectable HCV-RNA 24 weeks after the end of treatment for genotype 2 and 3.
次要结局
- Percentage of Participants With Adverse Event (AE)(Week 96)