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

NCT02631772 | Completed Phase 4 Results DMC

• 1 other identifier: IN-US-337-1830
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Treatment Efficacy

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

  12 Weeks

Secondary Outcomes (2)

• Number of Participants With Virologic Failure

  12 weeks

• Hemoglobin Levels

  Week 4, Week 8, Week 12, Week 16

Study Arms (2)

Late Cohort, Arm 1

EXPERIMENTAL

Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks

Drug: Sofosbuvir/Ledipasvir x 12 weeks

Late Cohort, Arm 2

ACTIVE COMPARATOR

Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks

Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Interventions

Sofosbuvir/Ledipasvir x 12 weeks DRUG

Also known as: Harvoni

Late Cohort, Arm 1

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks DRUG

Late Cohort, Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age and able to give informed consent
• History of HCV genotype 1 or 4
• Normal EKG
• At least 91 days post orthotopic liver transplant
• Screening laboratory values within defined thresholds
• Detectable HCV RNA at screening
• Creatinine Clearance of at least 40ml/min using the Cockcroft Gault equation
• Negative pregnancy test for female subjects within 48 hours prior to receiving study medication
• 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

You may not qualify if:

• Serious or active medical or psychiatric illness
• History of significant or unstable cardiac disease
• Stomach disorder that could interfere with the absorption of the study drug
• Pregnant or nursing females or males with a pregnant female partner
• Co-infected with Hepatits B (HBV) or HIV
• 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
• Allergic to or intolerant of sofosbuvir, ledipasvir, or ribavirin
• History of exposure to an Nonstructural protein (NS5A) inhibitor
• 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
• Participated in a clinical study with an investigational drug or biologic within the last 30 days
• Combined liver/kidney transplant
• History of organ transplant other than liver
• Childs Turcotte Pugh (CTP) B or C
• Patients with fibrosing cholestatic hepatitis
• Platelet count of ≤ 30 k/mm3

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (4)

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20057, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; ledipasvir, sofosbuvir drug combination; ledipasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Dr. Derek Dubay
• Organization: Medical University of South Carolina

dubay@musc.edu

843-792-3368

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 16, 2015
• Study Start: June 1, 2016
• Primary Completion: May 30, 2018
• Study Completion: June 30, 2018
• Last Updated: May 7, 2019
• Results First Posted: May 7, 2019

Record last verified: 2019-04

Locations

US (4)