Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients

Recruiting now · Phase 2

Conditions studied: Heart Failure

In brief

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®).

Key facts

Study ID

NCT03383419

Run by

Baylor Research Institute

People needed

15

Starts

2018-03-20

Expected to finish

2026-12-30

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Listed for combined organ transplant
• 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 prior solid organ transplant
• Pregnant individuals
• History of HIV infection
• 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
• Patients who have undergone or who will undergo immune desensitization therapy
• Prospective-positive cross-match or predicted positive cross-match
• Patients unwilling to notify their sexual partner(s) of participation in this trial

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
• Baylor University Medical Center — Dallas, Texas, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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