HCV Positive Heart Donors

Phase 4

Completed

• Conditions: Heart Failure
• Interventions: Combination Product: Transplant with HCV positive donor, followed by surveillance and treatment of viremia

• Registration Number: NCT03382847
• Lead Sponsor: NYU Langone Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-19
• Study First Posted: 2017-12-26
• Study Start: 2018-01-05
• Primary Completion: 2020-05-06
• Study Completion: 2020-05-06
• Status Verified: 2021-01
• Results First Submitted: 2021-01-14
• Results First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Results First Posted: 2021-02-03
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Transplant with HCV positive donor, followed by surveillance and treatment of viremia	HCV negative patients will receive a heart transplant from a HCV positive donor. Post-transplant, there will be surveillance for the development of viremia, and treatment of viremia. Following treatment, there will be surveillance for a sustained virologic response to HCV treatment.

Primary Outcome Measures

Name	Time	Method
Sustained Virologic Response After Treatment	1 year	Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.

Trial Locations

Locations (1)

NYU Langone Transplant Institute; 🇺🇸 New York, New York, United States