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LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

NCT02631772•Medical University of South Carolina

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. At least 18 years of age and able to give informed consent
•2. History of HCV genotype 1 or 4
•3. Normal EKG
•4. At least 91 days post orthotopic liver transplant
•5. Screening laboratory values within defined thresholds
•6. Detectable HCV RNA at screening
•7. Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
•8. Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
•9. Use of two effective contraception methods if female of childbearing potential or sexually active male unless status post bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy

Exclusion Criteria

•1. Serious or active medical or psychiatric illness
•2. History of significant or unstable cardiac disease
•3. Stomach disorder that could interfere with the absorption of the study drug
•4. Pregnant or nursing females or males with a pregnant female partner
•5. Co-infected with Hepatits B (HBV) or HIV
•6. Recipients of an allograft from a donor that was infected with HCV with an unknown genotype or non-genotype 1 or 4 unless the recipient is demonstrated to have only genotype 1 or 4 HCV replication post-transplant
•7. Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
•8. History of exposure to an Nonstructural protein (NS5A) inhibitor
•9. Within 1 year of transplant AND history of Hepatocellular Carcinoma (HCC) with tumor burden outside of the Milan Criteria (See Appendix II) prior to transplant
•10. Participated in a clinical study with an investigational drug or biologic within the last 30 days
+10 more criteria

Locations (4)

Medstar Georgetown University Hospital

Washington D.C., 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

Key Dates

Start Date

June 1, 2016

Primary Completion Date

May 30, 2018

Completion Date

June 30, 2018

Last Updated

May 7, 2019

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Sofosbuvir/Ledipasvir x 12 weeks

DRUG

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Implementing Low-Barrier HCV Treatment in a Jail Setting

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