Phase 4 Completed N=25 Treatment

HCV Positive Heart Donors

Heart Failure

Source: ClinicalTrials.gov NCT03382847 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Feb 2021

Primary outcomePrimary: Sustained Virologic Response After Treatment — 24 Participants

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained Virologic Response After Treatment	24	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.