Clinical trial NCT02631772: LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Official title: LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Treatment Efficacy
timeFrame: 12 Weeks
Secondary outcomes:
measure: Number of Participants With Virologic Failure
timeFrame: 12 weeks
measure: Hemoglobin Levels
timeFrame: Week 4, Week 8, Week 12, Week 16
Other outcomes:
Locations:
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: