CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 10 enrolled
Drug / intervention
Zepatier +2 moredrug
Likely dose
Zepatier 100 mgfrom 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/NCT02781649
NCT02781649Phase 4Completed
CompareCT.gov

An Open-label Pilot Study to Determine the Tolerability and Efficacy of Fixed-dose Grazoprevir/Elbasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors

Johns Hopkins University·interventional·Posted May 24, 2016·Updated Sep 6, 2018

In Brief

A Phase 4 clinical trial evaluating Zepatier, Ribavirin, and 1 other intervention for End-Stage Renal Disease and Hepatitis C. Completed, enrolled 10 participants across 1 site.

Detailed Summary

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd-Stage Renal Disease, Hepatitis C
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 24, 2016
Enrollment StartJul 20, 2016
Primary CompletionMay 3, 2017
Study CompletionJan 1, 2018
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.1 years ago

Interventions

Zepatierdrug

Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks

Ribavirindrug

Ribavirin 1200 mg/d (\> 75 kg) or 1000 mg/d (\< 75 kg) by mouth daily in two divided doses

Sofosbuvirdrug

Sofosbuvir 400 mg daily