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

NCT ID: NCT02631772

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2018-06-30

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

Conditions

Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Late Cohort, Arm 1

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

Group Type: EXPERIMENTAL

Sofosbuvir/Ledipasvir x 12 weeks

Intervention Type: DRUG

Late Cohort, Arm 2

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

Group Type: ACTIVE_COMPARATOR

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Intervention Type: DRUG

Interventions

Sofosbuvir/Ledipasvir x 12 weeks

Intervention Type: DRUG

Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Intervention Type: DRUG

Other Intervention Names

Harvoni

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IN-US-337-1830

Identifier Type: -

Identifier Source: org_study_id