A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 229
- 主要终点
- Sustained virological response
研究概览
简要总结
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 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 —（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;
- •treatment-naive.
排除标准
- •liver cirrhosis and other forms of liver disease;
- •HIV infection;
- •hepatocellular cancer;
- •cardiac disease.
研究组 & 干预措施
Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
干预措施: RO5190591 (Danoprevir) (Drug)
Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Placebo (Drug)
Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: RO5190591 (Danoprevir) (Drug)
Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: RO5190591 (Danoprevir) (Drug)
Part 2: Placebo
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 2: Placebo
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 2: Placebo
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.
干预措施: Placebo (Drug)
Part 2: RO5190591 300mg po
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Copegus (Drug)
Part 2: RO5190591 300mg po
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: Pegasys (Drug)
Part 2: RO5190591 300mg po
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
干预措施: RO5190591 (Danoprevir) (Drug)
结局指标
主要结局
Sustained virological response
时间窗: 24 weeks after end of treatment
次要结局
- Virological response over time(At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment)
- Adverse events; laboratory parameters(Throughout study, laboratory parameters every 2 to 6 weeks)