Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

• Status: Terminated
• Trial end date: 2019-03-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Sofosbuvir-velpatasvir drug combination

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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