NCT03383419 Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
| NCT ID | NCT03383419 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Baylor Research Institute |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2018-03-20 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 15 participants in total. It began in 2018-03-20 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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®).
Eligibility 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
Contact & Investigator
Shelley A Hall, MD, FACC, FHFSA
STUDY CHAIR
Baylor University Medical Center/ Baylor Scott & White Research Institute
Frequently Asked Questions
Who can join the NCT03383419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03383419 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03383419 currently recruiting?
Yes, NCT03383419 is actively recruiting participants. Contact the research team at Aayla.Jamil@BSWHealth.org for enrollment information.
Where is the NCT03383419 trial being conducted?
This trial is being conducted at Los Angeles, United States, Durham, United States, Dallas, United States.
Who is sponsoring the NCT03383419 clinical trial?
NCT03383419 is sponsored by Baylor Research Institute. The principal investigator is Shelley A Hall, MD, FACC, FHFSA at Baylor University Medical Center/ Baylor Scott & White Research Institute. The trial plans to enroll 15 participants.
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