CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
300mg glecaprevir/pibrentasivir 120mgdrug
Likely dose
300mg glecaprevir/pibrentasivir 120mgfrom 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/NCT03627299
NCT03627299Phase 4Completed
CompareCT.gov

An Open-label Pilot Study to Determine the Safety and Efficacy of Fixed-dose Glecaprevir and Pibrentasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors

Johns Hopkins University·interventional·Posted Aug 13, 2018·Updated Oct 19, 2021

In Brief

A Phase 4 clinical trial evaluating 300mg glecaprevir/pibrentasivir 120mg for End Stage Renal Disease and Hepatitis C. Completed, enrolled 11 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 glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease, Hepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2018
Enrollment StartSep 25, 2018
Primary CompletionDec 19, 2019
Study CompletionSep 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.9 years ago

Interventions

300mg glecaprevir/pibrentasivir 120mgdrug

300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant