CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Sofosbuvir/Ledipasvir x 12 weeks +1 moredrug
Likely dose
Not stated in 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/NCT02631772
NCT02631772Phase 4Completed
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LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Medical University of South Carolina·interventional·Posted Dec 16, 2015·Updated May 7, 2019

In Brief

A Phase 4 clinical trial evaluating Sofosbuvir/Ledipasvir x 12 weeks and Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks for Hepatitis C. Completed, enrolled 32 participants across 4 sites.

Detailed Summary

The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 16, 2015
Enrollment StartJun 1, 2016
Primary CompletionMay 30, 2018
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 10.5 years ago

Interventions

Sofosbuvir/Ledipasvir x 12 weeksdrug

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeksdrug