RecruitingPhase 2NCT03383419

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

Sponsor

Baylor Research Institute

Enrollment

15 participants

Start Date

Mar 20, 2018

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

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)

Exclusion Criteria13

Listed for combined organ transplant
Any of the following liver disease states, including:
History of HCV viremia detectable by either HCV qualitative or quantitative PCR unless deemed cured (SVR-12),
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,
Cirrhosis, as indicated by liver biopsy,
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,
History of prior solid organ transplant
Pregnant individuals
History of HIV infection
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
Patients who have undergone or who will undergo immune desensitization therapy
Prospective-positive cross-match or predicted positive cross-match
Patients unwilling to notify their sexual partner(s) of participation in this trial