CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 8 enrolled
Drug / intervention
elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)drug
Likely dose
elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)from 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/NCT02945150
NCT02945150Phase 4Completed
CompareCT.gov

A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Massachusetts General Hospital·interventional·Posted Oct 26, 2016·Updated Jun 9, 2020

In Brief

A Phase 4 clinical trial evaluating elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) for Renal Failure. Completed, enrolled 8 participants across 1 site.

Detailed Summary

Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.

Study Details

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

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 26, 2016
Enrollment StartFeb 1, 2017
Primary CompletionAug 20, 2019
Study CompletionMar 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 9.7 years ago

Interventions

elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)drug

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those \<75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).