A Proof of Concept Study for Preemptive Treatment With Grazoprevir and Elbasvir in Donor HCV-positive to Recipient HCV-negative Cardiac Transplant
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Undetectable HCV
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 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.
详细描述
Phase 1 of this study will be a single case study with only one subject enrolled. Once safety has been demonstrated and HCV infection transmission shown to be prevented by the protocol, the study will expand to 10 additional patients.
Patients will be selected based on their diminished likelihood of receiving a heart from the waitlist within a period during which they would be likely to succumb to severe comorbidities. This will be determined in part through use of a patient's listing status (1A, 1B, 2) and clinical judgment, and the Seattle Heart Failure Model.
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 grazoprevir + elbasvir +/- ribavirin
12 to 16 weeks of treatment with combination tablet of grazoprevir + elbasvir +/- ribavirin
干预措施: Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin (Drug)
结局指标
主要结局
Undetectable HCV
时间窗: 12 Weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment.
次要结局
- Safety and tolerability (based on number of adverse events and out of range lab values) of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone cardiac transplantation(Upto 16 Weeks)
研究者
Raymond T. Chung, MD
Director of Hepatology
Massachusetts General Hospital