Phase 4
N=25
HCV Positive Heart Donors
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03382847 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Feb 2021
Primary outcome: Primary: Sustained Virologic Response After Treatment — 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transplant with HCV positive donor, followed by surveillance and treatment of viremia (Combination_product)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response After Treatment |
24 | — |
Summary
Study subjects active on the waiting list for a heart transplant at the NYU Langone Transplant Institute who are hepatitis C (HCV) negative will receive a heart transplant from a donor who tests positive for HCV. The study will entail surveillance for the development of HCV viremia post-transplant. Patients who develop HCV viremia post-transplant will be treated with an FDA-approved, pan-genotypic direct acting antiviral drug, Mavyret. Patients who are treated with Mavyret will be monitored for clearance of viremia and for sustained virologic response.
Eligibility Criteria
Inclusion Criteria
- Listed for an isolated heart transplant at NYU Langone Health
- Able to travel to the NYU Langone Health for routine post-transplant visits and study visits for a minimum of 6 months after transplantation
- No active illicit substance abuse
- Weight at least 50kg
- Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy (REMS) after transplant due to the increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method after transplant to prevent any secretion exchange
- Able and willing to provide informed consent
Exclusion Criteria
- HIV positive
- HCV RNA positive or history of previously treated HCV
- Hepatitis B surface antigen positive or on active antiviral treatment for HBV
- Pregnant or nursing (lactating) women
- Use of strong CYP3A inducers
Data sourced from ClinicalTrials.gov (NCT03382847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.