Trial Outcomes & Findings for HCV Positive Heart Donors (NCT NCT03382847)

Last Updated: 2021-02-03

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

1 year

Results posted on

2021-02-03

Participant milestones
Measure	Intervention Arm 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. 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
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Withdrawal data not reported

HCV Positive Heart Donors

Baseline characteristics by cohort
Measure	Intervention Arm n=25 Participants 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. 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
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=93 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants
Age, Continuous	57 years STANDARD_DEVIATION 12 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	18 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants
Region of Enrollment United States	25 Participants n=93 Participants

Timeframe: 1 year

Population: 100% of surviving patients met this endpoint. One patient expired in the early post-operative period.

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

Outcome measures
Measure	Intervention Arm n=24 Participants 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. 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
Sustained Virologic Response After Treatment	24 Participants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events
Measure	Intervention Arm n=25 participants at risk 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. 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
Hepatobiliary disorders pancreatitis	4.0% 1/25 • Number of events 1 • 1 year

Adverse event data not reported

NYU LANGONE TRANSPLANT INSTITUTE

Phone: 2122638365