QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Number of Participants With Undetectable Blood HCV RNA Level
研究概览
简要总结
This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
详细描述
The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment with Direct Acting Antiviral for HCV
4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant
干预措施: Glecaprevir and Pibrentasvir (Drug)
结局指标
主要结局
Number of Participants With Undetectable Blood HCV RNA Level
时间窗: 12 weeks post last dose of treatment with G/P
Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P
次要结局
- Adverse Events(1 Year Study Period)
- HCV RNA Viral Load(Measured at Week 2 and Week 4 of Treatment;)
- Allograft Function(1 Year Study Period)
- Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation(1 Year Study Period)
研究者
Nahel Elias, M.D.
Surgical Director, Kidney Transplant
Massachusetts General Hospital