Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
研究概览
简要总结
The purpose of this study is to evaluate whether treatment with Epclusa (sofosbuvir/velpatasvir) after lung transplantation in individuals with chronic hepatitis C infection is feasible, safe and effective at curing HCV.
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
- •HCV RNA >= 10^3 IU/ml at screening
- •Chronic HCV infection, defined as positive HCV antibody and/or HCV RNA more than 6 months prior to screening
- •HCV Genotype 1, 2, 3, 4, 5 or 6
- •Otherwise eligible for lung transplant at study site
排除标准
- •Treatment with any of the following agents:
- •Amiodarone. Subjects previously treated with amiodarone must have stopped the amiodarone at least 60 days prior to day 1 SOF/VEL
- •Carbamazepine, phenytoin, phenobarbital, oxcarbazepine
- •Rifabutin, rifampin or rifapentine
- •HIV regimens containing tenofovir or tipranavir/ritonavir
- •St John's wort
- •PPIs, including: Omeprazole, pantoprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole
- •Modafinil
- •Have any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance
- •Hepatitis B surface antigen positive
- •History of hepatic encephalopathy or variceal hemorrhage
- •Abnormal hematological and biochemical parameters, including:
- •Hemoglobin <8g/dL
- •Platelets <= 50,000/mm^3
- •ALT (alanine aminotransferase), AST (aspartase aminotransferase) or alkaline phosphatase >=10 times ULN
- •Total bilirubin >3mg/dL
- •Severe renal impairment, ie creatinine clearance (CrCl) <30mL/min
- •Pregnant women or women planning to become pregnant
- •Women or are breastfeeding
- •Active or recent history (<=1 year) of drug or alcohol abuse
研究组 & 干预措施
Epclusa
Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
干预措施: Epclusa (Drug)
结局指标
主要结局
Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
时间窗: 12 weeks
Sustained Virologic Response 12 weeks (SVR 12) in those treated with EPCLUSA.
Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
时间窗: 1 year
Adverse events resulting in discontinuation of EPCLUSA
Number of Patients Eligible for EPCLUSA Treatment
时间窗: within 12 months of lung transplant
Eligibility for EPCLUSA treatment within 12 months of lung transplant
次要结局
- Change in Serum HCV RNA Levels(12, 24, and 48 weeks after initiation of EPCLUSA)
- Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy(1 year)
- Patient Survival(1 year post-transplant)