Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment



Status:Recruiting
Conditions:Hospital, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Other
Healthy:No
Age Range:18 - Any
Updated:10/20/2018
Start Date:September 15, 2017
End Date:September 15, 2019
Contact:Noely M Martinez Overby
Email:noely.martinez-overby@duke.edu
Phone:919-681-3791

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Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study

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.


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
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Alice Gray, MD
Phone: 919-681-3791
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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