Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
- Registration Number
- NCT03207399
- Lead Sponsor
- Duke University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1
- 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
-
Age <18
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Epclusa Epclusa Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
- Primary Outcome Measures
Name Time Method Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA. 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 1 year Adverse events resulting in discontinuation of EPCLUSA
Number of Patients Eligible for EPCLUSA Treatment within 12 months of lung transplant Eligibility for EPCLUSA treatment within 12 months of lung transplant
- Secondary Outcome Measures
Name Time Method Change in Serum HCV RNA Levels 12, 24, and 48 weeks after initiation of EPCLUSA Serum HCV RNA levels at 12-, 24-, and 48-weeks after initiation of EPCLUSA
Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy 1 year Adverse events requiring temporary interruption in EPCLUSA therapy
Patient Survival 1 year post-transplant 1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States