NCT04452578已完成不适用
Pilot Investigation Using HCV Positive Heart Grafts in HCV Negative or Previously Successfully Treated Recipients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Patient Survival Rate
研究概览
简要总结
To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV negative heart recipients who are currently listed.
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
- •Male or female
- •Age 18 and older
- •Active on the transplant list
- •Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
- •HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
- •Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject
- •Patients listed for multiple organ transplant (heart and kidney or heart and liver) can be included based on agreement of non-cardiac organ transplant team
排除标准
- •Participants co-infected with HIV
- •Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
- •Known allergies or hypersensitivity to DAA or ribavarin
- •Pregnancy and/or actively breastfeeding
结局指标
主要结局
Patient Survival Rate
时间窗: 15 months
次要结局
未报告次要终点
研究者
研究点 (2)
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