Heart Transplant with HCV-Positive Donors and Epclusa Treatment
This study is looking at whether hearts from donors with Hepatitis C (HCV) can be safely used for people needing a heart transplant who don't have HCV. The study will give a medication called Epclusa (sofosbuvir 400 mg / velpatasvir 100 mg) for 12 weeks if you develop HCV after the transplant. Researchers want to see if this treatment can cure the Hepatitis C. You might be able to join if you are 18 or older, are on the heart transplant waiting list, and do not have active Hepatitis C. The study aims to enroll 15 participants. The main goal is to see if participants achieve a sustained virologic response (meaning the Hepatitis C virus is no longer detectable) 12 weeks after finishing treatment.
- Study design
- This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It is designed to evaluate the safety and effectiveness of using HCV-positive donor hearts.
- What's involved
- You would receive a heart transplant from an HCV-positive donor. If you develop HCV after transplant, you would take Epclusa for 12 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your Hepatitis C levels will be checked regularly after the transplant, and the main success measure is taken 12 weeks after treatment ends.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
At a glance
Conditions
NCT03383419
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Baylor University Medical Center
Dallas, Texasstudy coordinator listed
Recruiting
Cedars-Sinai Medical Center
Los Angeles, Californiastudy coordinator listed
Recruiting
Duke University Medical Center
Durham, North Carolinano site contact published
Active, not recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Shelley A Hall, MD, FACC, FHFSA · STUDY_CHAIR · Baylor University Medical Center/ Baylor Scott & White Research Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Sustained virologic response after 12 weeks of treatment12 weeks
To evaluate the number of patients with sustained virologic response (SVR) 12 weeks after discontinuation of therapy.