CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Zepatierdrug
Likely dose
Zepatier 100mgfrom 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/NCT03146741
NCT03146741Phase 2Completed
CompareCT.gov

Open-Labeled Trial Of Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors

University of Pennsylvania·interventional·Posted May 10, 2017·Updated Nov 22, 2021

In Brief

A Phase 2 clinical trial evaluating Zepatier for Heart Failure. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study is being conducted to determine safety and effectiveness of transplanting hearts from Hepatitis C-positive donors into Hepatitis C-negative patients on the heart transplant waitlist, who will then be treated with Zepatier after transplantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartMay 16, 2017
Primary CompletionSep 10, 2019
Study CompletionNov 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.1 years ago

Interventions

Zepatierdrug

Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.