A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 496
- 试验地点
- 109
- 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 and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target 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
- •Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
- •HCV infection of sub-GT1b confirmed by genotypic testing at screening.
- •HCV viral load =1,000 IU/mL at randomisation.
- •Patients who have never been previously treated with any other HCV treatment regimen.
排除标准
- •HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
- •HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT
- •Liver disease due to causes other than chronic HCV infection.
- •HIV infection.
- •Hepatitis B virus infection based on presence of HBs-Ag.
- •Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
- •History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
- •Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
- •Decompensated liver disease, or history of decompensated liver disease.
- •Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
- •Red blood cell disorders.
- •Body weight <40 kg or >125 kg.
研究组 & 干预措施
Randomised 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
干预措施: BI 207127: 24-week treatment (Drug)
Randomised 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
干预措施: Faldaprevir: 24-week treatment (Drug)
Randomised 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
干预措施: RBV: 24-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: BI 207127-placebo: 8-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: Ribavirin-placebo: 8-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: Faldaprevir-placebo: 8-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: Faldaprevir: 16-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: Ribavirin: 16-week treatment (Drug)
Randomised 16-week arm
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
干预措施: BI 207127: 16-week treatment (Drug)
Allocated 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
干预措施: Ribavirin: 24-week treatment (Drug)
Allocated 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
干预措施: Faldaprevir: 24-week treatment (Drug)
Allocated 24-week arm
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
干预措施: BI 207127: 24-week treatment (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 (HCV) RNA level \<25 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. The number of participants analyzed are actually adjusted number of participant analyzed.
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: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.(4 weeks (after End Of Treatment))
- SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.(4 weeks (after End Of Treatment))
- Prognostic Value of SVR12 Predicting SVR24(24 Week (post-treatment))