HCV Positive Heart Donors

Heart Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382847
• Other study ID #: 17-01775
• Status: Completed
• Phase: Phase 4
• Start date: January 5, 2018
• Est. completion date: May 6, 2020

Study information

• Verified date: January 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 6, 2020
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Combination Product:
• Transplant with HCV positive donor, followed by surveillance and treatment of viremia
Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs

Locations

Country	Name	City	State
United States	NYU Langone Transplant Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained Virologic Response After Treatment	Percentage of patients with sustained virologic response after treatment for HCV after heart transplant.	1 year