LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Phase 4

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks; Drug: Sofosbuvir/Ledipasvir x 12 weeks

• Registration Number: NCT02631772
• Lead Sponsor: Medical University of South Carolina

Brief 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

Detailed Description

This is a multicenter, prospective, randomized, open-label phase IV study.

Compare ledipasvir/sofosbuvir + ribavirin for 12 weeks vs ledipasvir/sofosbuvir alone for 12 weeks in patients over 90 days post-liver transplant

Study Timeline

• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-14
• Study First Posted: 2015-12-16
• Study Start: 2016-06-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-06-30
• Results First Submitted: 2019-03-19
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-12
• Last Update Submitted: 2019-04-12
• Results First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late Cohort, Arm 2	Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks	Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks
Late Cohort, Arm 1	Sofosbuvir/Ledipasvir x 12 weeks	Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks

Primary Outcome Measures

Name	Time	Method
Treatment Efficacy	12 Weeks	Treatment efficacy, defined as the percentage of patients achieving sustained virologic response 12 (SVR12) weeks after completing the antiviral regimen

Secondary Outcome Measures

Name	Time	Method
Hemoglobin Levels	Week 4, Week 8, Week 12, Week 16	Change in hemoglobin levels over the course of the study
Number of Participants With Virologic Failure	12 weeks	Number of participants who had a nonresponse to treatment or a relapse of disease under study.

Trial Locations

Locations (4)

Medstar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States