An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study
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 12 Weeks After Discontinuation of Therapy (SVR12)
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Willing and able to provide written informed consent
- •Infection with HCV genotype 1
- •HCV RNA > LLOQ at screening
- •Participation in a prior Gilead-sponsored study
- •Screening laboratory values within defined thresholds
- •Use of two effective contraception methods if female of childbearing potential or sexually active male
- •Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
- •Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
排除标准
- •Pregnant or nursing female or male with pregnant female partner
- •Co-infection with HIV or hepatitis B virus (HBV)
- •Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
- •Hepatocellular carcinoma (HCC)
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LDV/SOF+RBV 12 weeks (Group 1)
Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 weeks (Group 1)
Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: RBV (Drug)
LDV/SOF 24 weeks (Group 2)
Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 weeks (Group 3)
Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
时间窗: Post-treatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 Weeks
次要结局
- Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ While on Treatment(Baseline to Week 24)
- Change in HCV RNA From Baseline(Baseline to Week 8)
- Percentage of Participants With Virologic Failure(Up to posttreatment Week 24)