drugset / Trial / NCT03382847

HCV Positive Heart Donors

NCT03382847

Phase 4 Completed 25 enrolled NYU Langone Health
NaSingle-groupOpen-labelTreatment

Summary

Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.

Timeline

Start
2018-01-05
Primary completion
2020-05-06
Completion
2020-05-06

Drugs

EvaluationDrugModalityDoseRoute
Subject glecaprevir Other / unclassified

Indications