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.
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