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 |
Trial Parameters
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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
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