NCT02631772

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Sofosbuvir/Ledipasvir x 12 weeks
DRUG	Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-05-30
• Completion: 2018-06-30
• First posted: 2015-12-16
• Last updated: 2019-05-07
• Results posted: 2019-05-07

Locations

4 sites across 1 country: United States