A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 87
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
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
- •HCV RNA > 15 IU/mL at screening
- •HCV genotype 1 or 4
- •Chronic HCV infection (≥ 6 months)
- •Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
- •Cirrhotic and non-cirrhotic as determined by standard methods
- •Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
排除标准
- •Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
- •Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
- •Pregnant or nursing female or male with pregnant female partner
- •Coinfection with HIV or hepatitis B virus
- •Current or prior history of clinical hepatic decompensation
- •Hepatocellular carcinoma 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 individual's 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 12 weeks, without cirrhosis
LDV/SOF for 12 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF + RBV 12 weeks, without cirrhosis
LDV/SOF + RBV for 12 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF + RBV 12 weeks, without cirrhosis
LDV/SOF + RBV for 12 weeks
干预措施: RBV (Drug)
LDV/SOF + RBV 12 weeks, with compensated cirrhosis
LDV/SOF + RBV for 12 weeks
干预措施: LDV/SOF (Drug)
LDV/SOF + RBV 12 weeks, with compensated cirrhosis
LDV/SOF + RBV for 12 weeks
干预措施: RBV (Drug)
LDV/SOF 24 weeks, with compensated cirrhosis
LDV/SOF for 24 weeks
干预措施: LDV/SOF (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
时间窗: Posttreatment Week 12
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
时间窗: Up to 24 weeks
次要结局
- Number of Participants With Emerging Resistance(Up to Posttreatment Week 24)
- Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Viral Relapse(Up to Posttreatment Week 24)
- Percentage of Participants With Viral Breakthrough(Up to 24 weeks)