Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Undetectable Blood HCV RNA Level
研究概览
简要总结
This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
详细描述
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after lungs transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCVpositive donor lung to an HCV naïve 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, listed for lung transplant
- •Able to sign informed consent
排除标准
- •Pregnant or nursing (lactating) women
- •HIV positivity
- •Any contra-indication to lung transplantation per center protocol
- •For study patients in whom Epclusa® therapy is being considered, exclusion criteria includes patients on the following p-glycoprotein inducers or moderate to potent CYP inducers that cannot stop therapy: carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, rifapentine, St. John's wort.
- •For study patients in whom MavyretTM therapy is being considered, exclusion criteria includes patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
研究组 & 干预措施
Treatment with Direct Acting Antiviral for HCV
8 weeks of treatment with HCV Direct Acting Antiviral tablet (Mavyret or Epclusa)
干预措施: Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 8 weeks (Drug)
结局指标
主要结局
Undetectable Blood HCV RNA Level
时间窗: 12 weeks post last dose of treatment with DAA
Negative HCV RNA by blood testing at 12 weeks after the last dose of treatment.
次要结局
- Number of Participants With Treatment Emergent Adverse Events(8 weeks)
- Tolerability (Based on Number of Adverse Events and Clinically Significant Laboratory Values)(8 weeks)
研究者
Raymond Chung
Director of Hepatology
Massachusetts General Hospital