Phase 4
Completed N=32
LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients
Source: ClinicalTrials.gov NCT02631772 ↗Enrolled (actual)
32
Serious AEs
50.0%
Results posted
May 2019
Primary outcomePrimary: Treatment Efficacy — 88; 75 % of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Efficacy |
88; 75 | — |
| SECONDARY Number of Participants With Virologic Failure |
0; 1; 1; 2 | — |
| SECONDARY Hemoglobin Levels |
13.1; 12.9; 13.3; 11.2; 13.7; 12.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- Hemoglobin 10mg/dL
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase ≥ 10x upper limit normal
- Serum sodium < 125mmol/L
- 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
Data sourced from ClinicalTrials.gov (NCT02631772). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.