A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 273
- 主要终点
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
研究概览
简要总结
This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.
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
- •Chronic HCV infection
- •Cirrhosis determination (liver biopsy may be required)
- •Screening laboratory values within specified limits
- •Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •Specific genotype, prior medical history, or concurrent disease as required by the specific study group
排除标准
- •History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- •Pregnant or nursing female, or male with pregnant female partner
- •Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
- •Use of any prohibited concomitant medications
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.
干预措施: SOF/VEL (Drug)
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.
干预措施: RBV (Drug)
LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)
Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.
干预措施: RBV (Drug)
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: LDV/SOF (Drug)
LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)
Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.
干预措施: RBV (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.
干预措施: VOX (Drug)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.
干预措施: VOX (Drug)
结局指标
主要结局
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 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, 15 IU/mL) at 12 weeks after stopping study treatment.
次要结局
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit(Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3))