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Belatacept in De Novo Heart Transplantation
NCT04477629 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04477629
The ClinicalTrials.gov registry entry for NCT04477629 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04477629 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04477629?
The interventions under investigation include: Corticosteroid (DRUG), Mycophenolate Mofetil (DRUG), Tacrolimus (DRUG), Belatacept (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04477629?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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