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Completed

NCT Number: NCT03382847

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 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Transplant Institute

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transplant with HCV positive donor, followed by surveillance and treatment of viremia

Combination Product

Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs

Primary outcomes

  1. Sustained Virologic Response After Treatment

    Time frame: 1 year

    Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single-center Pilot Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Heart Transplant Recipients With Post-transplant Treatment of Hepatitis C Viremia With Mavyret

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2017
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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