Recruiting
Phase 2

Sofosbuvir & Velpatasvir

Sponsor:

Baylor Research Institute

Code:

NCT03383419

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Epclusa

Study Details

Brief 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®).

Conditions

Heart Failure

Study ID

NCT03383419

Start date

Mar 20, 2018

Status verified date

Oct, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Epclusa

If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.

Primary outcome measure

  • Sustained virologic response after 12 weeks of treatment [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Evan Kransdorf, MD

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Robert L Gottlieb, MD

More Information

Sponsor

Baylor Research Institute

Last update posted

Jan 22, 2026

Last verified

Oct, 2025

Keywords

  • Heart Failure, Heart Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor Research Institute on 2026-01-22.