drugset / Trial / NCT03112044

Lung Transplant HCV, Pilot Study

NCT03112044

Phase 0 Active not recruiting 26 enrolled University Health Network, Toronto Gilead Sciences · collab
NaSingle-groupOpen-labelTreatment

Summary

In this study HCV negative recipients will be transplanted with HCV positive lungs. Investigators will attempt to decrease infectivity rates by performing Normothermic Ex vivo Lung Perfusion (EVLP), which is an approved method of donor lung preservation, assessment and treatment, and could be an excellent platform to reduce/eliminate hepatitis C virus. Patients will be treated by the standard approved direct-acting antivirals (DAAs) if infection occurs. It is planned to enroll 20 patients from the Lung transplant wait list in this study. Patients will be actively followed for 6 months including HCV PCR tests and then for up for 5 years to look for evidence of HCV infection and any liver or extra-hepatic complications, as well as standard post-transplant complications. This will be a single center pilot study.

Timeline

Start
2017-09-19
Primary completion
2020-01-02
Completion
2027-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Sofosbuvir Small molecule 400 mg Oral
Subject velpatasvir Other / unclassified 100 mg Oral