Assessing hepatitis eradication after heart transplant from HCV infected donors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.