Lung Transplantation in Chronic HCV Infection With Post Transplant EPCLUSA Treatment

NCT ID: NCT03207399

Last Updated: 2019-09-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-15
• Study Completion Date: 2019-03-25

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.

Conditions

Hepatitis C, Chronic; Lung Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Epclusa

Epclusa (sofosbuvir 400mg/velpatasvir 100mg) 1 tablet oral or via tube daily for 12 weeks, taken with or without food.

Group Type: OTHER

Epclusa

Intervention Type: DRUG

Patients will be treated with this drug for 12 weeks post lung transplant.

Interventions

Epclusa

Patients will be treated with this drug for 12 weeks post lung transplant.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omar Mohamedaly, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Heath

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00074361

Identifier Type: -

Identifier Source: org_study_id