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Belatacept for Heart Transplant

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Heart TransplantBelatacept - Drug
Eligibility
18 - 75
All Sexes
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Study Summary

This trial is testing if an anti-rejection medication called Belatacept is safe for adult heart transplant patients.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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belatacept
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arTreg-CSB

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 18 months

18 months
Percentage of Individuals with Development of De Novo Donor Specific Antibodies (DSA)
Baseline and 18 months
Change in Estimated Glomerular Filtration Rate (eGFR)
Month 18
Number of Major Graft-Related Adverse Events

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
belatacept
2
Rituximab
1
arTreg-CSB

Side Effects for

Belatacept
67%COPD exacerbation
This histogram enumerates side effects from a completed 2016 Phase 4 trial (NCT02078193) in the Belatacept ARM group. Side effects include: COPD exacerbation with 67%.

Trial Design

1 Treatment Group

Belatacept
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Belatacept · No Placebo Group · Phase 2

BelataceptExperimental Group · 4 Interventions: Corticosteroid, Belatacept, Tacrolimus, Mycophenolate Mofetil · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroid
2005
Completed Phase 4
~2100
Belatacept
FDA approved
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,263 Previous Clinical Trials
753,585 Total Patients Enrolled
Marlena V. HabalLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,496 Previous Clinical Trials
3,930,315 Total Patients Enrolled
Marlena V. Habal, MDPrincipal Investigator - NYU Langone Health
New York Presbyterian Hospital-Columbia Presbyterian Center, Trustees of Columbia University in the City of New York

Eligibility Criteria

Age 18 - 75 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a minimum age of 18 to 75 years.
You have antibodies to Epstein-Barr virus (EBV).
You are female and of childbearing potential.
You are awaiting a primary heart transplant.
You are able to take oral medication and willing to adhere to the belatacept infusion regimen.
References

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