Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Stopped early · Phase 4
Conditions studied: Hepatitis C, Chronic, Lung Transplant
In brief
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.
Key facts
- Study ID
- NCT03207399
- Run by
- Duke University
- People needed
- 1
- Starts
- 2017-09-15
- Expected to finish
- 2019-03-25
- Last updated by the study team
- 2019-09-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Duke University Medical Center — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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