HCV Positive Heart Donors

NCT03382847 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 17-01775
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response After Treatment

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

  1 year

Study Arms (1)

Intervention arm

EXPERIMENTAL

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.

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

Interventions

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

Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Transplant Institute

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Bonnie Lonze
• Organization: NYU LANGONE TRANSPLANT INSTITUTE

Bonnie.Lonze@nyumc.org

2122638365

Study Officials

• Alex Reyentovich, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 26, 2017
• Study Start: January 5, 2018
• Primary Completion: May 6, 2020
• Study Completion: May 6, 2020
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)