Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Undetectable HCV RNA
研究概览
简要总结
This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
详细描述
The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive 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
- •Met MGH transplant center criteria and already listed for kidney transplant
- •Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
- •No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
- •Able to sign informed consent
排除标准
- •Pregnant or nursing (lactating) women
- •HBV positivity (Ag or DNA)
- •Any contra-indication to kidney transplantation per center protocol
- •Donor Inclusion Criteria
- •Detectable HCV NAT test
- •KDPI score is less than ≤ 0.850
- •Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation
- •Donor Exclusion Criteria
- •Confirmed HIV
- •Confirmed HBV positive (surface antigen or HBV DNA positive)
- •Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
研究组 & 干预措施
Treatment with Direct Acting Antiviral for HCV
8 weeks of treatment with HCV Direct Acting Antiviral tablet
干预措施: Direct Acting Antivirals (Drug)
结局指标
主要结局
Undetectable HCV RNA
时间窗: 12 weeks post-treatment
Negative HCV RNA 12 weeks after last dose of treatment
Rate of Serious and non-serious adverse events
时间窗: 1 year post-transplant
Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment
次要结局
未报告次要终点
研究者
Nahel Elias, M.D.
Surgical Director, Kidney Transplant
Massachusetts General Hospital