NCT03650920已完成不适用
Pilot Investigation Using HCV Positive Liver 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
- 89
- 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 sero-negative liver 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 nucleic acid test (NAT) positive for HCV
- •Graft with F2 fibrosis or less at time of explant
- •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
排除标准
- •Participants co-infected with HIV
- •Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
- •Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
- •Pregnancy and/or actively breastfeeding
结局指标
主要结局
Patient survival rate
时间窗: From the date of transplant through the last day of 15 month post transplant
Will track all subjects post transplant for 15 months
次要结局
未报告次要终点
研究者
Michael Volk
Director of Transplant Hepatology
Loma Linda University
研究点 (2)
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