A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
详细描述
Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high dose both given in combination with RBV for 12 weeks.
Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day 1 through end of follow-up for virologic breakthrough or relapse.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects (male and female) must be between 18-60 years of age
- •Subjects must have Chronic Hepatitis C
- •Subjects must be treatment naive
- •Subjects must have laboratory values at screening within limits as specified by the protocol
排除标准
- •Evidence of cirrhosis
- •Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
- •any other cause of significant liver disease in addition to hepatitis C
- •Diagnosis of or suspected hepatocellular carcinoma
研究组 & 干预措施
VX-135 low dose in combination with ribavirin
12 weeks of VX-135 in combination with ribavirin
干预措施: VX-135 (Drug)
VX-135 low dose in combination with ribavirin
12 weeks of VX-135 in combination with ribavirin
干预措施: Ribavirin (Drug)
VX-135 high dose in combination with ribavirin
干预措施: VX-135 (Drug)
VX-135 high dose in combination with ribavirin
干预措施: Ribavirin (Drug)
结局指标
主要结局
Safety
时间窗: Week 12
The safety and tolerability as assessed by evaluating adverse events and laboratory testing.
次要结局
- evidence of HCV RNA viral load reduction(16 weeks)