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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