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NCT04477629RECRUITINGIRB Ready

Belatacept in De Novo Heart Transplantation

Sponsored by NYU Langone Health

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
📊
1 of 12 participants interested
8% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

Male or non-pregnant female, age ≥18 to ≤75 years 2. Awaiting a primary heart transplant (listed for heart transplant only) 3. Epstein-Barr virus (EBV) IgG seropositive 4. Able to take oral medication and willing to adhere to the belatacept infusion regimen 5. No desensitization therapy prior to transplant 6. Vaccinations should be up to date for hepatitis B, influenza pneumococcal, haemophilus, varicella zoster virus (VZV), measles, mumps and rubella (MMR), and Human Papilloma Virus (HPV) (for participants \< 45 years of age) when available 7. Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization 8. Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted 9. Negative virtual crossmatch

Exclusion Criteria

Candidates awaiting multiorgan transplant 2. Estimated glomerular filtration rate (eGFR) \< 45 ml/min/m2 3. Candidates with p

❓ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

12 participants

🎂

Age Range

18 Years - 75 Years

Gender

ALL

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Sponsor

NYU Langone Health

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

New York

New York

Location available
ACTIVE_NOT_RECRUITING

New York

New York

Location available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

🔒 Secure · 🏥 Expert Care

Looking for Heart Transplant Treatment in New York?

Join others in New York exploring innovative treatment options through clinical research

Heart Transplant Treatment Options in New York, New York

If you're searching for Heart Transplant treatment in New York, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in New York, New York and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Heart Transplant. All study-related care is provided at no cost to participants.

Local Sites
2 locations in New York
Now Enrolling
Up to 12 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Heart Transplant?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Heart Transplant

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Heart Transplant Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT04477629. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.