Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
Who is this study for? Patients with Heart Failure
What treatments are being studied? Epclusa
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Willing and capable of providing written informed consent
• Age ≥ 18 years
• Listed for isolated orthotopic heart transplant
• 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)
Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
North Carolina
Duke University Medical Center
ACTIVE_NOT_RECRUITING
Durham
Texas
Baylor University Medical Center
RECRUITING
Dallas
Contact Information
Primary
Aayla Jamil, MBBS MPH
Aayla.Jamil@BSWHealth.org
214-820-1675
Time Frame
Start Date: 2018-03-20
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 15
Treatments
Experimental: Treatment
Epclusa® will be started within 14 days of quantifiable viremia and continued for 12 weeks. Within 24 hours prior to first-dose of treatment, HCV genotype will be sent from transplant recipient.
Authors
Robert Gottlieb
Related Therapeutic Areas
Sponsors
Leads: Baylor Research Institute