Belatacept in De Novo Heart Transplantation - Pilot 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).
• Male or non-pregnant female, age ≥18 to ≤75 years
• Awaiting a primary heart transplant (listed for heart transplant only)
• Epstein-Barr virus (EBV) IgG seropositive
• Able to take oral medication and willing to adhere to the belatacept infusion regimen
• No desensitization therapy prior to transplant
• 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
• Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) prior to randomization
• Mechanical support or investigational drug trials where the intervention ends at the time of transplantation are permitted
• Negative virtual crossmatch