Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Overview
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.
Full Title of Study: “Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 25, 2019
Interventions
- Drug: Epclusa
- Patients will be treated with this drug for 12 weeks post lung transplant.
Arms, Groups and Cohorts
- Other: Epclusa
- Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
Clinical Trial Outcome Measures
Primary Measures
- Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
- Time Frame: 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
- Time Frame: 1 year
- Adverse events resulting in discontinuation of EPCLUSA
- Number of Patients Eligible for EPCLUSA Treatment
- Time Frame: within 12 months of lung transplant
- Eligibility for EPCLUSA treatment within 12 months of lung transplant
Secondary Measures
- Change in Serum HCV RNA Levels
- Time Frame: 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
- Time Frame: 1 year
- Adverse events requiring temporary interruption in EPCLUSA therapy
- Patient Survival
- Time Frame: 90 days post-transplant
- 90-day post transplant patient survival
- Patient Survival
- Time Frame: 1 year post-tranplant
- 1 year post transplant patient survival
- Patient Survival
- Time Frame: 90 days post-transplant
- 90-day post transplant patient survival in recipients of HCV NAT positive donor organ
- Patient Survival
- Time Frame: 1 year post-transplant
- 1 year post transplant patient survival in recipients of HCV NAT positive donor organ
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Duke University
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Omar Mohamedaly, MD, Principal Investigator, Duke Heath
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