LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Treatment Efficacy
研究概览
简要总结
The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft.
Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study
详细描述
This is a multicenter, prospective, randomized, open-label phase IV study.
Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Late Cohort, Arm 1
Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks
干预措施: Sofosbuvir/Ledipasvir x 12 weeks (Drug)
Late Cohort, Arm 2
Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks
干预措施: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks (Drug)
结局指标
主要结局
Treatment Efficacy
时间窗: 12 Weeks
Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen
次要结局
- Hemoglobin Levels(Week 4, Week 8, Week 12, Week 16)
- Number of Participants With Virologic Failure(12 weeks)