A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 107
- 主要终点
- Adverse events (AEs) and laboratory parameters.
研究概览
简要总结
This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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;
- •CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
- •chronic liver disease consistent with CHC.
排除标准
- •infection with any HCV genotype other than genotype 1;
- •previous treatment for CHC;
- •medical condition associated with chronic liver disease other than CHC;
- •HIV, Hepatitis A, Hepatitis B infection.
研究组 & 干预措施
RO5024048 in combination with PEGASYS and COPEGUS
干预措施: PEGASYS (Drug)
PEGASYS with COPEGUS
干预措施: Copegus (Drug)
PEGASYS with COPEGUS
干预措施: PEGASYS (Drug)
RO5024048 1500mg in combination with PEGASYS
干预措施: PEGASYS (Drug)
RO5024048 1500mg in combination with PEGASYS
干预措施: RO5024048 1500mg (Drug)
RO5024048 3000mg in combination with PEGASYS
干预措施: PEGASYS (Drug)
RO5024048 3000mg in combination with PEGASYS
干预措施: RO5024048 3000mg (Drug)
RO5024048 in combination with PEGASYS and COPEGUS
干预措施: Copegus (Drug)
RO5024048 in combination with PEGASYS and COPEGUS
干预措施: RO5024048 1500mg (Drug)
结局指标
主要结局
Adverse events (AEs) and laboratory parameters.
时间窗: Week 4, 8 and Week 72
次要结局
- Plasma concentration of HCV polymerase inhibitor(Week 4 and 8)
- Antiviral activity(Week 4, 8 and Week 72)