CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 25 enrolled
Drug / intervention
Transplant with HCV positive donor, followed by surveillance and treatment of viremiacombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03382847
NCT03382847Phase 4Completed

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret

NYU Langone Health·interventional·Posted Dec 26, 2017·Updated Feb 3, 2021

In Brief

A Phase 4 clinical trial evaluating Transplant with HCV positive donor, followed by surveillance and treatment of viremia for Heart Failure. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 26, 2017
Enrollment StartJan 5, 2018
Primary CompletionMay 6, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.5 years ago

Interventions

Transplant with HCV positive donor, followed by surveillance and treatment of viremiacombination

Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs