A Phase III, Randomized, Partially Double-Blind and Placebo-Controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Treatment-Naive Patients With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 101
- 主要终点
- SVR12 Rates With Historical Control
研究概览
简要总结
The aim of the study is to confirm efficacy of treatment for 16 and 24 weeks in chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
干预措施: Ribavirin (RBV) (Drug)
Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
干预措施: BI 201335 (Faldaprevir) (Drug)
Allocated 24 weeks BI 207127 + BI 201335
24 weeks of BI 207127 and BI 201335 in combination with Ribavirin
干预措施: BI 207127 (Drug)
Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
干预措施: BI 201335 (Faldaprevir) (Drug)
Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
干预措施: Ribavirin (RBV) (Drug)
Randomized 16 weeks BI 7127+BI1335 + RBV
16 weeks of BI 207127 and QD BI 201335 RBV, followed by additional 8 weeks of placebo BI 207127+ placebo BI 201335 in combination with placebo RBV
干预措施: BI 207127 (Drug)
Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
干预措施: Ribavirin (RBV) (Drug)
Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
干预措施: BI 207127 (Drug)
Randomized 24weeks BI 7127+ BI1335 + RBV
24 weeks of BI 207127and BI 201335 in combination with RBV
干预措施: Faldaprevir (BI 201335) (Drug)
结局指标
主要结局
SVR12 Rates With Historical Control
时间窗: 12 Week (post-treatment)
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C Virus ribonucleic acid (HCV RNA) level \<25 international units/millilitre (IU/mL) at 12 weeks after End of Treatment (EoT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint
Comparisons of SVR12 Rates Across Treatment Arms
时间窗: 12 Week (post-treatment)
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
次要结局
- SVR4(4 Week (post-treatment))
- SVR24(24 Week (post-treatment))