Clinical trial NCT03207399: Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment
Official title: Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment: A Pilot Feasibility and Efficacy Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lung Transplant
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Sustained Virologic Response 12 Weeks (SVR 12) in Those Treated With EPCLUSA.
timeFrame: 12 weeks
measure: Number of Patients That Reported an Adverse Event Resulting in Discontinuation of EPCLUSA
timeFrame: 1 year
measure: Number of Patients Eligible for EPCLUSA Treatment
timeFrame: within 12 months of lung transplant
Secondary outcomes:
measure: Change in Serum HCV RNA Levels
timeFrame: 12, 24, and 48 weeks after initiation of EPCLUSA
measure: Number of Participants With Adverse Events Requiring Temporary Interruption of EPCLUSA Therapy
timeFrame: 1 year
measure: Patient Survival
timeFrame: 90 days post-transplant
measure: Patient Survival
timeFrame: 1 year post-tranplant
measure: Patient Survival
timeFrame: 90 days post-transplant
measure: Patient Survival
timeFrame: 1 year post-transplant
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Heath
name: Omar Mohamedaly, MD
role: PRINCIPAL_INVESTIGATOR
References: