NCT03382847

HCV Positive Heart Donors

Completed Phase 4 Results posted Last updated 3 February 2021

What this trial tests

Phase 4 trial testing Transplant with HCV positive donor, followed by surveillance and treatment of viremia in Heart Failure in 25 participants. Completed in 6 May 2020.

Timeline

5 January 2018

Primary endpoint
6 May 2020

6 May 2020

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	5 January 2018
Primary completion	6 May 2020
Estimated completion	6 May 2020
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Heart Failure — all drugs for Heart Failure →

Sponsor

NYU Langone Health — full company profile →

Who can join

Eligibility, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sustained Virologic Response After Treatment Primary · 1 year

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

Group	Value	95% CI
Intervention Arm	24

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention Arm

Serious: 1/25 (4%)

Deaths: 1/25

Serious adverse events (1 terms)

Reaction	System	Intervention Arm
pancreatitis	Hepatobiliary disorders	—

Most-reported serious reactions: pancreatitis.

Data from ClinicalTrials.gov NCT03382847 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. The New Direct Antiviral Agents and Hepatitis C in Thoracic Transplantation: Impact on Donors and Recipients.
   Gottlieb RL, Hall SA. · · 2018 · cited 9× · PMID 29774177 · DOI 10.1007/s40472-018-0192-y
2. Clinical and Financial Implications of 2 Treatment Strategies for Donor-derived Hepatitis C Infections.
   Stewart ZA, Stern J, Ali NM, Kalia HS, et al · · 2021 · cited 8× · PMID 34514117 · DOI 10.1097/txd.0000000000001222