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

Recruiting Phase 2 Interventional Study
Heart Failure
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 90
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
15 (estimated)
Sponsor
Baylor Research Institute · Other
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About This Trial

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®).

Trial Locations
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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-…
Contacts

Aayla Jamil, MBBS MPH

214-820-1675

Aayla.Jamil@BSWHealth.org

CONTACT