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 |
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.
(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
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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