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Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

Phase 4
Terminated
Conditions
Hepatitis C, Chronic
Lung Transplant
Interventions
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
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
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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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
EpclusaEpclusaEpclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.
Primary Outcome Measures
NameTimeMethod
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 EPCLUSA1 year

Adverse events resulting in discontinuation of EPCLUSA

Number of Patients Eligible for EPCLUSA Treatmentwithin 12 months of lung transplant

Eligibility for EPCLUSA treatment within 12 months of lung transplant

Secondary Outcome Measures
NameTimeMethod
Change in Serum HCV RNA Levels12, 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 Therapy1 year

Adverse events requiring temporary interruption in EPCLUSA therapy

Patient Survival1 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

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