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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02631772
Recruitment Status : Completed
First Posted : December 16, 2015
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Description
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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


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Sofosbuvir/Ledipasvir x 12 weeks Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Actual Study Start Date : June 1, 2016
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: Late Cohort, Arm 1
Ledispasvir (LDV) and Sofosbuvir (SOF) monotherapy x 12 weeks
 Drug: Sofosbuvir/Ledipasvir x 12 weeks
Other Name: Harvoni
Active Comparator: Late Cohort, Arm 2
Ledispasvir (LDV) and Sofosbuvir (SOF) +ribavirin x 12 weeks
 Drug: Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Efficacy [ Time Frame: 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 :
  1. Number of Participants With Virologic Failure [ Time Frame: 12 weeks ]
    Number of participants who had a nonresponse to treatment or a relapse of disease under study.

  2. Hemoglobin Levels [ Time Frame: Week 4, Week 8, Week 12, Week 16 ]
    Change in hemoglobin levels over the course of the study


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  11. Combined liver/kidney transplant
  12. History of organ transplant other than liver
  13. Childs Turcotte Pugh (CTP) B or C
  14. Patients with fibrosing cholestatic hepatitis
  15. Platelet count of ≤ 30 k/mm3
  16. Hemoglobin < 10g/dL
  17. Total bilirubin > 10mg/dL
  18. Alanine aminotransferase (ALT),aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
  19. Serum sodium < 125mmol/L
  20. Current use of any of the Prohibited Interventions (Section 5.3.2) and un-willing to discontinue use, or use of amiodarone within 6 months of screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631772


Locations
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United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20057
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
  Study Documents (Full-Text)

Documents provided by Medical University of South Carolina:
Study Protocol and Statistical Analysis Plan  [PDF] March 7, 2017

More Information
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT02631772    
Other Study ID Numbers: IN-US-337-1830
First Posted: December 16, 2015    Key Record Dates
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Ribavirin
Sofosbuvir
Ledipasvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents