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Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 to 90

Using hepatitis C–positive donor hearts for hepatitis C–negative recipients treated with Epclusa

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

Run by Baylor Research Institute · NCT03383419 · Data updated 2026-11-12

This test will see if giving Epclusa to hepatitis C–negative heart transplant recipients prevents hepatitis C infection and allows safe use of hearts from HCV-positive donors.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment15 (estimated)
SponsorBaylor Research Institute
Academic / other
Locations3 sites (Los Angeles, California and 2 other locations)
StatusRecruiting
StartedMarch 20, 2018
Main results expectedDecember 30, 2026
Study endsDecember 30, 2026
Registry record updatedJanuary 22, 2026
Trial IDNCT03383419 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) listed for isolated orthotopic heart transplant who are HCV seronegative (or previously cleared infection with documented negative PCRs) and willing to accept an HCV-positive donor heart are ideal candidates.

Probably not a fit

Patients listed for combined organ transplants, those with active or uncured HCV viremia, cirrhosis, active hepatitis B infection, or other listed exclusion criteria are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II, multicenter, open-label protocol enrolls adults listed for isolated orthotopic heart transplant who are HCV seronegative or have documented prior clearance. Consented participants who accept an HCV-NAT–positive donor heart are closely monitored with serial HCV PCR testing and donor HCV NAT/genotype analysis. If recipients develop confirmed HCV viremia post-transplant, they receive a 12-week course of sofosbuvir 400 mg/velpatasvir 100 mg (Epclusa) provided by the sponsor. Patients lacking hepatitis B immunity are encouraged to begin hepatitis B vaccination and all participants are followed through the post-transplant period per protocol.

Why it matters

Potential benefit: If successful, this approach could expand the donor heart pool and let more patients get transplants sooner while preventing chronic HCV infection with antiviral therapy.

How similar studies have gone: Similar protocols using direct-acting antivirals to permit transplantation of HCV-positive donor kidneys and livers into HCV-negative recipients have shown high cure rates, and this trial applies that approach to heart transplantation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Willing and capable of providing written informed consent
2. Age ≥ 18 years
3. Listed for isolated orthotopic heart transplant
4. 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 Criteria:

1. Listed for combined organ transplant
2. Any of the following liver disease states, including:

   1. History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
   2. 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,
   3. Cirrhosis, as indicated by liver biopsy,
   4. 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,
3. History of prior solid organ transplant
4. Pregnant individuals
5. History of HIV infection
6. 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
7. Patients who have undergone or who will undergo immune desensitization therapy
8. Prospective-positive cross-match or predicted positive cross-match
9. Patients unwilling to notify their sexual partner(s) of participation in this trial

Where it's running

  • Cedars-Sinai Medical Center
    Los Angeles, California, United States     Recruiting
  • Baylor University Medical Center
    Dallas, Texas, United States     Recruiting
  • Duke University Medical Center
    Durham, North Carolina, United States     Active not recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.