A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
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 ≥ 18 years, with chronic genotype 1 HCV infection
- •HCV RNA equal to or greater than 10,000 IU/mL at screening
- •Cirrhosis determination; a liver biopsy may be required
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Current or prior history of clinical hepatic decompensation
- •Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
- •Chronic use of systemic immunosuppressive agents
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
研究组 & 干预措施
LDV/SOF 8 Weeks (TN)
Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 8 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks.
干预措施: RBV (Drug)
LDV/SOF 12 Weeks (TN)
Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF 12 Weeks (TE)
Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks (TE)
Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
时间窗: Baseline to Week 12
The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
次要结局
- Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24)(Posttreatment Weeks 2, 4, 8, and 24)
- Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse(Baseline to Posttreatment Week 24)