NCT02781571已完成2 期
A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects With Chronic HCV Infection Who Have Received a Liver Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 15
- 主要终点
- Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
研究概览
简要总结
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •History of chronic HCV infection (≥ 6 months)
- •HCV genotype 1, 2, 3, 4, 5, 6, or indeterminate
- •Liver transplant ≥ 3 months prior to screening
- •Male and nonpregnant/ non-lactating female individuals without cirrhosis or with compensated cirrhosis
排除标准
- •History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol,
- •Co-infection with HIV or hepatitis B virus
- •Known hypersensitivity to study medication,
- •Use of any prohibited concomitant medications as within with window before the Day 1 visit.
- •De novo or recurrent hepatocellular carcinoma posttransplant
- •NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
SOF/VEL
Experimental
SOF/VEL FDC for 12 weeks
干预措施: SOF/VEL (Drug)
结局指标
主要结局
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
时间窗: Up to 12 weeks
Percentage of Participants With Sustained Virologic Response (SVR) 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) at 12 weeks after stopping study treatment.
次要结局
- HCV RNA at Week 12(Week 12)
- Change From Baseline in HCV RNA at Week 2(Baseline; Week 2)
- Change From Baseline in HCV RNA at Week 4(Baseline; Week 4)
- Change From Baseline in HCV RNA at Week 8(Baseline; Week 8)
- Change From Baseline in HCV RNA at Week 12(Baseline; Week 12)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
- Percentage of Participants With HCV RNA < LLOQ at Week 2(Week 2)
- Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)(Posttreatment Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 4(Week 4)
- Percentage of Participants With HCV RNA < LLOQ at Week 12(Week 12)
- HCV RNA at Week 2(Week 2)
- HCV RNA at Week 4(Week 4)
- HCV RNA at Week 8(Week 8)
- Percentage of Participants With HCV RNA < LLOQ at Week 8(Week 8)
研究者
研究点 (15)
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