An Open-Label Phase 2a Study Evaluating the Safety and Efficacy of Combination Treatment With 2 Weeks of the Non-Nucleoside Inhibitor CDI 31244 Plus 6 Weeks of Sofosbuvir/Velpatasvir in Subjects With Chronic Hepatitis C Genotype 1 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
研究概览
简要总结
Open label phase 2a study of two week treatment with CDI-31244 and sofosbuvir and veltapasvir followed by four week treatment of sofosbuvir and velpatasvir in individuals with chronic hepatitis C (HCV) genotype 1 (GT1) infection
详细描述
The study is open label and has one treatment group. Eligible HCV GT1 subjects will self administer orally 400 mg of CDI-31244 and fixed dose combination of sofosbuvir and velpatasvir for 14 days. After 14 days the subjects will continue the treatment for another 4 weeks on the fixed dose combination sofosbuvir and velpatasvir. The subjects will be followed up until 24 weeks after the last dose of sofosbuvir and velpatasvir to determine if sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks after treatment have been achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Documented chronic HCV GT 1 infection; Serum HCV RNA >1,000 IU/mL during screening; Absence of advanced fibrosis or cirrhosis
排除标准
- •Nursing or pregnant women; Active hepatitis B infection; Human immunodeficiency virus (HIV) infection; History of use of any HCV direct-acting antiviral therapy
研究组 & 干预措施
CDI-31244 + SOF/VEL
CDI-31244 in combination with SOF/VEL
干预措施: CDI-31244 (Drug)
CDI-31244 + SOF/VEL
CDI-31244 in combination with SOF/VEL
干预措施: SOF/VEL (Drug)
结局指标
主要结局
Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After Treatment
时间窗: post-treatment Week 12
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after treatment
Number of Subjects With Treatment Emergent Adverse Events
时间窗: Day 1 to Day 72
The safety and the tolerability of CDI-31244 in combination with SOF/VEL through number of AEs observed in participants
次要结局
- Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After Discontinuation of Therapy(post-treatment Week 24)