Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.
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
- 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
- •Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
- •Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
- •HCV RNA > 10,000 IU/mL at Screening;
- •Screening laboratory values within defined thresholds;
- •Negative pregnancy test at baseline (females of childbearing potential only);
- •Use of two effective contraception methods if female of childbearing potential or sexually active male.
排除标准
- •Pregnant or nursing female;
- •HIV infection or HBV infection (HBcAb and HBsAg positive);
- •Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
- •Active or recent history (≤ 1 year) of drug or alcohol abuse;
- •Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
研究组 & 干预措施
Sofosbuvir and Daclatasvir
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
干预措施: sofosbuvir and daclatasvir (Drug)
Ledipasvir/sofosbuvir
Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
干预措施: ledipasvir/sofosbuvir (Drug)
结局指标
主要结局
Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
时间窗: Post treatment Week 12
SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ \< 25 IU/mL) 12 weeks following the last dose of study medication
Incidence of adverse events leading to permanent discontinuation of study drug
时间窗: Baseline up to Week 12
次要结局
- Treatment adherence(Baseline to Week 12)
- Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment(Baseline up to Week 12)
- HCV RNA levels and change during and after treatment(Baseline up to Week 12)
- Change in health related quality of life(Baseline to Week 24)