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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631772
• Other study ID #: IN-US-337-1830
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• Sofosbuvir/Ledipasvir x 12 weeks

• Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Virologic Failure	Number of participants who had a nonresponse to treatment or a relapse of disease under study.	12 weeks
Secondary	Hemoglobin Levels	Change in hemoglobin levels over the course of the study	Week 4, Week 8, Week 12, Week 16