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NCT04477629 · ClinicalTrials.gov registry record · Phase 2
Belatacept in De Novo Heart Transplantation
A Phase 2 study of Heart Transplantation, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT04477629: Recruiting Phase 2 study of Heart Transplantation, sponsored by NYU Langone Health.
NCT04477629 is a Phase 2 study of Heart Transplantation that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 12 participants, below the 589-participant average among 4 other Heart Transplantation trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477629, a Phase 2 study of Heart Transplantation, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (not for the purpose that it is approved for).
Primary Outcome
Adverse events that will be counted in the total number include: Episodes of acute cellular rejection ≥ 2R/3A, antibody mediated rejection (AMR) ≥ International Society of Heart and Lung Transplantation (ISHLT) AMR 1, hemodynamically compromised rejection, development of cardiac allograft vasculopathy, graft failure occurring ≥ 14 days post-transplant, the need for re-transplant, serious infection requiring inpatient intravenous therapies, post-transplant lymphoproliferative disorder (PTLD), or
Conditions Studied
Interventions
- DRUG Corticosteroid
- DRUG Mycophenolate Mofetil
- DRUG Tacrolimus
- DRUG Belatacept
Study Locations (2)
New York
- NYU Langone Health - New York
- Columbia University - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT04477629 shows while recruiting
NCT04477629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 589-participant average among 4 other Heart Transplantation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Heart Transplantation appearing as the primary indexed condition, and to 4 interventions - of which Corticosteroid is the first listed.
NCT04477629 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04477629 about?
NCT04477629 is a clinical study titled "Belatacept in De Novo Heart Transplantation". The purpose of this study is to determine if Belatacept is safe to give to adult heart transplant recipients. Belatacept (NULOJIX) is an anti-rejection medication that is available through a prescription from a doctor. In this research study, belatacept is being used in an investigational manner (no...
What is the current status of trial NCT04477629?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2020-08-06. Estimated completion is 2026-09.
What conditions does trial NCT04477629 study?
This clinical trial studies the following conditions: Heart Transplantation.
What interventions are being tested in trial NCT04477629?
The interventions under investigation include: Corticosteroid (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Belatacept (DRUG).
Who is sponsoring clinical trial NCT04477629?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04477629 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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