RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study drug, Epclusa®, comes in bottles that contain 28 tablets each."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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®).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 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, 3. History of prior solid organ transplant 4. Pregnant individuals 5. History of HIV infection 6. 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 7. Patients who have undergone or who will undergo immune desensitization therapy 8. Prospective-positive cross-match or predicted positive cross-match 9. Patients unwilling to notify their sexual partner(s) of participation in this trial

Study sites (3)

CA

NC

TX