Testing Epclusa in heart transplant patients receiving hearts from hepatitis C donors
Tests Epclusa in adults receiving hearts from hepatitis C-positive donors.
Plain-language title generated from the registry record
Registry title: Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Key facts
- Where
- Dallas, Durham, and Los Angeles, United StatesSee the 3 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Source: NCT03383419, who can take part
Where in United States
- Baylor University Medical CenterDallas, United StatesTaking people
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Cedars-Sinai Medical CenterLos Angeles, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Baylor Research Institute
- Trial code
- NCT03383419
- Record updated
- 22 January 2026
- Original description
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).Read full original descriptionShow less
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
This phase II, multi-center, open-label study will evaluate the safety and efficacy of utilizing HCV-positive donors for heart transplant in HCV-negative recipients treated with sofosbuvir 400 mg / velpatasvir 100 mg (Epclusa®).
Inclusion: Willing and capable of providing written informed consent; Age ≥ 18 years; Listed for isolated orthotopic heart transplant; HCV seronegative (or, if HCV seropositive, then subject must be PCR negative on at least 2 draws consistent with a spontaneously cleared or fully-treated and cleared prior infection; in this case last anti-HCV antiviral dose must be ≥12 weeks ago and 2 negative titers ≥12 weeks after completion of the antiviral regimen).
Exclusion: Listed for combined organ transplant; History of prior solid organ transplant; Patients who have undergone or who will undergo immune desensitization therapy; History of HIV infection; Any of the following liver disease states, including:; History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),; Hepatitis B surface Ag positive(unless clinically determined to be previously negative and acutely positive due to vaccination with recombinant surface antigen) or detectable hepatitis B DNA,; Cirrhosis, as indicated by liver biopsy,; Portal hypertension as indicated by a hepatic venous pressure gradient > 5 mm Hg and/or the presence of esophageal varices e.) ALT and AST > 3x ULN unless adjudicated to be from a non-hepatic cardiac or skeletal muscle source,; History of severe renal disease currently requiring dialysis. Chronic kidney disease with creatinine clearance <30 ml/min/1.73m2 (by MDRD method) at screening or on last two consecutive measurements before acceptance of transplant organ offer; Pregnant individuals; Prospective-positive cross-match or predicted positive cross-match; Patients unwilling to notify their sexual partner(s) of participation in this trial.