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

NCT03383419 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-22

No results posted yet for this study

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

Interventions

DRUG

Epclusa

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

Sponsors & Collaborators

  • Baylor Research Institute

    lead OTHER

Principal Investigators

  • Shelley A Hall, MD, FACC, FHFSA · Baylor University Medical Center/ Baylor Scott & White Research Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03383419 on ClinicalTrials.gov