Assessing hepatitis eradication after heart transplant from HCV infected donors
The Study of Hepatitis Eradication Receiving Protease Inhibitor Administration
This study is testing if a new treatment can help heart transplant patients who receive organs from donors with hepatitis C to clear the virus and stay healthy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sentara Norfolk General Hospital Academic / other |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT03886077 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety, tolerability, and antiviral efficacy of glecaprevir/pibrentasivir therapy in heart transplant recipients who receive organs from HCV-positive donors. Patients will be enrolled while on the transplant waitlist and will be monitored for HCV viral load post-transplant. The study includes two groups: those receiving HCV-negative organs and those receiving HCV-positive organs, with the latter confirmed to have acquired HCV infection. The study aims to provide insights into managing HCV in transplant patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older on the UNOS list for heart transplant.
Not a fit: Patients with advanced liver disease, active hepatitis B or C, or those who are HIV positive will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies for heart transplant recipients and reduce the risk of HCV infection.
How similar studies have performed: While similar studies have explored organ transplantation from HCV-positive donors, this specific approach using glecaprevir/pibrentasivir is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects must meet all of the inclusion criteria specified below in order to be eligible for participation in this study 1. Willing and capable of providing written informed consent 2. Age ≥18 years 3. On UNOS list as a candidate for heart transplant Exclusion Criteria: * Subjects who meet any of the following exclusion criteria cannot be enrolled in this study. 1. Individuals under 18 years of age 2. History of advanced liver disease, including active hepatitis B or C, detectable hepatitis B surface Ag, hepatitis B DNA, HCV RNA, or cirrhosis 3. Pregnant individuals 4. HIV antibody positive
Where this trial is running
Norfolk, Virginia
- Sentara Norfolk General Hospital — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: David Baran, MD — Sentara Norfolk General Hospital
- Study coordinator: David Baran, MD
- Email: dabaran@sentara.com
- Phone: 7573882831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.