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Immunosuppressant
Belatacept for Heart Transplant
Phase 2
Recruiting
Led By Marlena V. Habal, MD
Research Sponsored by Marlena V. Habal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No desensitization therapy prior to transplant
Male or non-pregnant female, age ≥18 to ≤75 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study Summary
This trial is testing if an anti-rejection medication called Belatacept is safe for adult heart transplant patients.
Who is the study for?
Adults aged 18-75 awaiting a primary heart transplant, who are EBV seropositive and can take oral meds. They must adhere to belatacept infusion schedule, have up-to-date vaccinations, and females of childbearing age need a negative pregnancy test. Excludes those with prior transplants, certain infections like HIV/HBV/HCV/TB, recent live vaccines, cancer in the last 5 years, high PRA levels or severe allergies to monoclonal antibodies.Check my eligibility
What is being tested?
The trial is testing if Belatacept is safe for adult heart transplant recipients as an anti-rejection medication. It's being used investigatively alongside standard post-transplant drugs such as corticosteroids, tacrolimus and mycophenolate mofetil.See study design
What are the potential side effects?
Belatacept may cause side effects including risk of infection due to immune suppression, possible allergic reactions related to infusions and interactions with other medications typically used after transplantation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not undergone desensitization therapy before a transplant.
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I am between 18 and 75 years old and not pregnant.
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I can take pills and follow a schedule for receiving belatacept infusions.
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I am a woman who can have children and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Major Graft-Related Adverse Events
Secondary outcome measures
Change in Estimated Glomerular Filtration Rate (eGFR)
Percentage of Individuals with Development of De Novo Donor Specific Antibodies (DSA)
Side effects data
From 2016 Phase 4 trial • 3 Patients • NCT0207819367%
COPD exacerbation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belatacept
Trial Design
1Treatment groups
Experimental Treatment
Group I: BelataceptExperimental Treatment4 Interventions
Participants will receive Belatacept along with an upfront tacrolimus taper Participants will also receive mycophenolate mofetil and corticosteroids are part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Corticosteroid
2005
Completed Phase 4
~2210
Belatacept
FDA approved
Tacrolimus
FDA approved
Mycophenolate mofetil
FDA approved
Find a Location
Who is running the clinical trial?
Marlena V. HabalLead Sponsor
NYU Langone HealthLead Sponsor
1,370 Previous Clinical Trials
840,792 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,645 Previous Clinical Trials
4,130,948 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you have any medical issues that aren't mentioned in the criteria above, and they might interfere with your ability to participate in the study or affect the accuracy of the results, you may not be eligible.You are waiting to receive a new heart.I am not currently in a trial that involves treatment at the time of my transplant.I do not have any active infections, except for possible driveline infections.I might need dialysis after a transplant.I have been treated with belatacept or abatacept before.I have not undergone desensitization therapy before a transplant.I am in a trial for a device or drug that ends with my transplantation.I have had active tuberculosis in the past.You have had an organ transplant in the past.I have been treated with cytolytic therapy before.I am planned to receive cell-killing therapy after a transplant.I have or had HIV, Hepatitis B, or Hepatitis C.I have untreated latent TB.I have been screened for TB and treated if it was found.I have not received a live vaccine in the last 30 days.I was diagnosed with cancer within the last 5 years.I have been treated with alkylating agents or had total lymphoid irradiation.I am a heart transplant candidate with high immune response or undergoing desensitization treatment.I have taken medication for rheumatic disease in the last year.I might be treated with a specific transplant medication other than Prograf.I was not on a heart-lung machine for more than 72 hours after my transplant.I require strong medication to maintain my blood pressure more than 3 days after a transplant.I am between 18 and 75 years old and not pregnant.I can take pills and follow a schedule for receiving belatacept infusions.My vaccinations for hepatitis B, flu, pneumonia, haemophilus, chickenpox, MMR, and HPV (if I'm under 45) are current.I am a woman who can have children and have a negative pregnancy test.You are waiting for a transplant of multiple organs.I have had a brain or spinal cord infection before.I am currently on medication to suppress my immune system.
Research Study Groups:
This trial has the following groups:- Group 1: Belatacept
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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