CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
Post-transplant Grazoprevir and Elbasvirdrug
Likely dose
Post-transplant Grazoprevir and Elbasvir 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/NCT02902120
NCT02902120Phase 4Completed
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Host Mechanisms Involved in Achieving SVR Using Grazoprevir and Elbasvir in Treatment of Chronic Hepatitis C in Patients With CKD Before and After Renal Transplantation

University of Maryland, Baltimore·interventional·Posted Sep 15, 2016·Updated Apr 22, 2024

In Brief

A Phase 4 clinical trial evaluating Post-transplant Grazoprevir and Elbasvir for Hepatitis C and 2 related conditions. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether patients treated for chronic hepatitis C (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant. 25 patients with chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune function will be monitored in both groups to determine their response to therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Renal Insufficiency, Chronic, Disorder of Transplanted Kidney
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 15, 2016
Enrollment StartMay 1, 2017
Primary CompletionSep 1, 2021
Study CompletionJun 8, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.8 years ago

Interventions

Post-transplant Grazoprevir and Elbasvirdrug

Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)