A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
This important study is investigating a new treatment called nipocalimab for pregnant women at risk of a condition called Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT). FNAIT is a rare but serious condition where a mother's immune system attacks her baby's platelets, which are essential for blood clotting. This can lead to severe bleeding in the baby, sometimes in the brain. The study aims to see if nipocalimab is better and safer than existing treatments like Intravenous Immunoglobulin (IVIG) in preventing FNAIT and its complications. Participants are pregnant women who have previously had a baby affected by FNAIT. By comparing these treatments, researchers hope to improve outcomes for future babies at risk.
At a glance
What is this study about?
This study is focused on a condition called Fetal and Neonatal Alloimmune Thrombocytopenia, or FNAIT. In simple terms, FNAIT happens when the mother's immune system produces special proteins called antibodies that cross the placenta and attack the baby's platelets. Platelets are tiny blood cells that help stop bleeding. If a baby has too few platelets, they can be at risk of serious bleeding, sometimes even before birth.
For mothers who have had a baby with FNAIT before, there's a higher chance it could happen again in future pregnancies. Current standard treatments aim to reduce these antibodies or protect the baby's platelets. This study is exploring a new medicine called nipocalimab. It works by blocking a specific pathway in the immune system that creates these harmful antibodies, potentially offering a more targeted and effective way to prevent FNAIT.
The main goal is to see if nipocalimab can significantly reduce the risk of severe FNAIT in babies, compared to current common treatments like IVIG (Intravenous Immunoglobulin). By understanding how well nipocalimab works and if it's safe for both mother and baby, researchers hope to offer better prevention strategies to families facing this challenging condition.
Key takeaways
- Studies a new drug (nipocalimab) for preventing serious baby bleeding (FNAIT).
- Compares nipocalimab to current treatments like IVIG.
- Aims to improve outcomes for babies at risk of FNAIT.
- Open to pregnant women with a history of FNAIT.
- Careful monitoring of both mother and baby throughout.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for pregnant women between 18 and 45 years old. To be considered, you must be between 13 and 18 weeks pregnant (or 12 weeks for high-risk cases) and have a clear history of a previous pregnancy affected by FNAIT. This means a past baby had low platelet counts, or worse, experienced bleeding in the brain or severe other bleeding due to FNAIT.
We would also need to confirm that your current baby is at risk by detecting specific antibodies in your blood that attack your baby's platelets, and that your baby has the corresponding platelet type. You should be generally healthy, as determined by a doctor's check-up and some routine tests. Both you and your baby would need to agree not to take part in any other studies involving new medicines until the end of this study's follow-up.
Unfortunately, you wouldn't be able to join if you're pregnant with twins or more, have a history of severe preeclampsia, certain heart conditions like a heart attack or stroke, or if you have known allergies to any of the study medications (nipocalimab, IVIG, or prednisone). We also cannot include individuals with certain immune system problems, either confirmed in you or running in your family, unless it's certain you don't have it.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you pregnant and between 18 and 45 years old?
- Are you between 13-18 weeks pregnant (or 12 weeks if high-risk)?
- Have you previously had a baby affected by FNAIT (e.g., low platelets or bleeding)?
- Have tests confirmed your current baby is at risk for FNAIT?
- Are you generally healthy, with no unmanaged serious health conditions?
- Are you able and willing to attend all study visits and medical appointments?
What does participation involve?
If you decide to take part, you would be assigned to receive either the new medicine nipocalimab, or one of the standard treatments (IVIG or prednisone). The study involves regular visits to the clinic for assessments, which will include physical examinations, blood tests, and scans to monitor your health and your baby's development. You would receive the study medication according to a schedule determined by the research team. After your baby is born, there will be follow-up appointments for both you and your baby. The total duration of your participation, including follow-up, could extend some time after your baby's birth, ensuring we gather all necessary safety and effectiveness information.
Potential risks and benefits
Locations (25)
- The University of Alabama at BirminghamVerified postcodeBirmingham, United States· Recruiting
- UC Davis School of MedicineVerified postcodeSacramento, United States· Recruiting
- Childrens Hospital ColoradoVerified postcodeAurora, United States· Recruiting
- Advocate Children's HospitalVerified postcodePark Ridge, United States· Recruiting
- University of Iowa Hospital and ClinicsVerified postcodeIowa City, United States· Recruiting
- University of North Carolina at Chapel HillVerified postcodeChapel Hill, United States· Recruiting
- University of CincinnatiVerified postcodeCincinnati, United States· Recruiting
- Oregon Health And Science UniversityVerified postcodePortland, United States· Recruiting
- Hospital of the University of PennsylvaniaVerified postcodePhiladelphia, United States· Recruiting
- University of Texas Medical BranchVerified postcodeGalveston, United States· Recruiting
- University of UtahVerified postcodeSalt Lake City, United States· Recruiting
- Medizinische Universitaet GrazVerified postcodeGraz, Austria· Recruiting
Common questions
What is FNAIT?
FNAIT (Fetal and Neonatal Alloimmune Thrombocytopenia) is a serious condition where a mother's immune system mistakenly attacks her baby's platelets, which are vital for blood clotting. This can cause severe bleeding in the baby.
What are platelets and why are they important?
Platelets are small cells in your blood that help it to clot. If you don't have enough platelets, you can bleed very easily or have difficulty stopping bleeding.
What is nipocalimab?
Nipocalimab is a new experimental medicine being tested to see if it can prevent FNAIT by stopping the mother's immune system from making harmful antibodies against the baby's platelets.
What is IVIG?
IVIG (Intravenous Immunoglobulin) is a standard treatment for FNAIT. It involves giving a patient a purified mixture of antibodies from healthy donors, which can help to reduce the harmful antibodies in the mother's blood.
Will I know which treatment I'm receiving?
In some studies like this, participants are 'blinded,' meaning they don't know whether they are receiving the new drug or an existing treatment. This helps ensure the study results are unbiased. The study team will explain how this works when you discuss participation.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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