A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination 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
- 205
- 试验地点
- 34
- 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
This primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) ± ribavirin (RBV) in adults with chronic genotype 1 hepatitis C virus (HCV) infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Individuals with chronic HCV infection
- •HCV RNA ≥10^4 IU/mL at screening
- •HCV genotype 1
- •Cirrhosis determination; a liver biopsy may be required
- •Screening laboratory values within defined thresholds
- •Use of two contraception methods if female of childbearing potential or sexually active male
排除标准
- •Pregnant or nursing female
- •Current or prior history of hepatic decompensation
- •Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •History of clinically significant illness or any other medical disorder that may interfere with the 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
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 8 wk, TN, without cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, without cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 6 wk, TN, with cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 8 wk, TN, with cirrhosis
VOX + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL+RBV 8 wk, TN, with cirrhosis
VOX + SOF/VEL+RBV for 8 weeks (treatment naive, with cirrhosis)
干预措施: RBV (Drug)
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 8 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 8 weeks (direct-acting antiviral experienced (DAA-E), without cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 12 wk, DAA-E, without cirrhosis
VOX + SOF/VEL for 12 weeks (direct-acting antiviral experienced, without cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 8 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (direct-acting antiviral experienced, with cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
干预措施: VOX (Drug)
VOX+SOF/VEL 12 wk, DAA-E, with cirrhosis
GS-9857 + SOF/VEL for 12 weeks (direct-acting antiviral experienced, with cirrhosis)
干预措施: SOF/VEL (Drug)
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
干预措施: VOX (Drug)
VOX+SOF/VEL 12 wk (GS-US-338-1121)
VOX + SOF/VEL for 12 weeks (participants who were previously enrolled in GS-US-338-1121 phase 1b study)
干预措施: SOF/VEL (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: Posttreatment 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 12 Weeks
次要结局
- Percentage of Participants With HCV RNA < LLOQ on Treatment(Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable))
- HCV RNA Change From Baseline(Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable))
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)