Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Liver Transplant
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
研究概览
简要总结
This is a single center study for the donation of Hepatitis C Virus (HCV)-positive livers to HCV negative recipient patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
详细描述
Patients will be selected based on diminished likelihood of receiving a liver 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 Model of End Stage Liver Disease (MELD) score, listing status, and clinical judgment. To ensure maximal benefit for the recipient, only high quality donor livers will be accepted.
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
- •Met Massachusetts General Hospital (MGH) transplant center criteria, listed for liver transplant
- •HCV naïve
- •Able to sign informed consent
排除标准
- •Pregnant or nursing (lactating) women
- •Human immunodeficiency virus (HIV) positivity
- •Need for dual organ transplant
- •Any contra-indication to liver transplantation per center protocol
研究组 & 干预措施
Treatment with Direct Acting Antiviral (DAA) Fixed Dose Combination
12 weeks of HCV treatment with medically appropriate direct acting antiviral
干预措施: Treatment with Direct Acting Antiviral tablet (Drug)
结局指标
主要结局
Number of Participants With Undetectable Hepatitis C Virus (HCV) Viral RNA
时间窗: 12 weeks post treatment
Number of dosed subjects with negative HCV viral RNA at 12 weeks after the last dose of treatment.
次要结局
- Number of Participants With Treatment Emergent Adverse Events and Out of Range Lab Values(12 weeks)
研究者
Raymond Chung
Director of Hepatology
Massachusetts General Hospital