A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
研究概览
简要总结
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.
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
- •Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation
- •HCV RNA ≥ 10,000 IU/mL at screening
- •Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit
- •Liver transplant ≥ 6 months and ≤ 12 years prior to screening
- •Naive to all nucleotide/nucleoside treatments for chronic HCV infection
排除标准
- •Multiorgan transplant that includes heart or lung recipient
- •Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant
- •Current use of corticosteroids at any dose > 5mg of prednisone/day (or equivalent dose of corticosteroid)
- •Infection with hepatitis B virus (HBV) or HIV at screening
- •Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
研究组 & 干预措施
SOF+RBV
Participants will receive sofosbuvir+RBV for 24 weeks.
干预措施: Sofosbuvir (Drug)
SOF+RBV
Participants will receive sofosbuvir+RBV for 24 weeks.
干预措施: RBV (Drug)
结局指标
主要结局
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
时间窗: Baseline to Week 24
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; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
次要结局
- Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)(Posttreatment Weeks 4, 24, and 48)
- Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24(Weeks 12 and 24)
- HCV RNA and Change From Baseline at Weeks 2, 4, and 8(Baseline; Weeks 2, 4, and 8)
- Percentage of Participants With Virologic Failure(Up to Posttreatment Week 24)