Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Heart Transplant
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
研究概览
简要总结
This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
详细描述
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after cardiac transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor heart to an HCV naïve recipient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Recipient is Age ≥ 18 years
- •Serum ALT within normal limits with no history of liver disease
- •Lack of sensitization (i.e. PRA < 20%) that would be expected to result in a high likelihood of needing aggressive immunosuppression to treat rejection
排除标准
- •Sensitization (i.e. PRA >20%)
- •Any liver disease in recipient
- •Albumin < 3g/dl or platelet count < 75 x 103/mL
- •Need for dual organ transplant
研究组 & 干预措施
Treatment with Direct Acting Antiviral for HCV
12 weeks of treatment with HCV Direct Acting Antiviral tablet
干预措施: Clinically prescribed direct acting antiviral (Drug)
结局指标
主要结局
Number of Participants With Undetectable HCV RNA at 12 Weeks Post Treatment
时间窗: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
次要结局
- Number of Participants With Adverse Events and Clinically Significant Out of Range Lab Values of DAA Therapy in Patients Undergoing Cardiac Transplantation(12 weeks)
研究者
Raymond Chung
Director of Hepatology
Massachusetts General Hospital