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HCV Positive Heart Donors | Clinical Trials | Clareo Health

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COMPLETEDPhase 4NCT03382847

HCV Positive Heart Donors

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 posit...

Lead sponsor: NYU Langone Health•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

NYU Langone Health

Age

All ages

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 3, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment25

Start dateJan 2018

Last updatedFeb 3, 2021

Condition

Locations shown

NYU Langone Transplant Institute

New York, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 3, 2021Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions