A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection and Child-Pugh Class B Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 268
- 主要终点
- Percentage of Participants With Sustained Virologic Response (SVR) 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 sofosbuvir (SOF)/velpatasvir (VEL) fixed dose combination (FDC) with and without ribavirin (RBV) for 12 weeks and SOF/VEL FDC for 24 weeks in adults with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) class B 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
- •Willing and able to provide written informed consent
- •HCV RNA > 10^4 IU/mL at screening
- •Chronic HCV infection (≥ 6 months)
- •Confirmed CPT class B (7-9) at screening
排除标准
- •Current or prior history of solid organ transplantation, significant pulmonary disease, significant cardiac disease, or porphyria
- •Inability to exclude hepatocellular carcinoma (HCC) by imaging within 6 months of baseline/Day 1
- •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- •Screening ECG with clinically significant abnormalities
- •Prior exposure to SOF or any other nucleotide analogue HCV nonstructural protein 5B (NS5B) inhibitor or any HCV NS5A inhibitor
- •Laboratory results outside of acceptable ranges at screening
研究组 & 干预措施
SOF/VEL 12 weeks
Participants will receive SOF/VEL FDC for 12 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+RBV 12 weeks
Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
干预措施: SOF/VEL (Drug)
SOF/VEL+RBV 12 weeks
Participants will receive SOF/VEL FDC plus RBV for 12 weeks.
干预措施: RBV (Drug)
SOF/VEL 24 weeks
Participants will receive SOF/VEL FDC for 24 weeks.
干预措施: SOF/VEL (Drug)
结局指标
主要结局
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) 12 weeks following the last dose of study drug.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
时间窗: Up to 24 weeks plus 30 days
次要结局
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)(Posttreatment Weeks 4 and 24)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24(Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24(Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)
- Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score(Baseline to Posttreatment Week 24)
- Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score(Baseline to Posttreatment Week 24)