IPA2002 FNAIT Natural History Study
Research type
Research Study
Full title
A prospective, natural history study to assess the occurrence of HPA-1a alloimmunization in women identified at higher risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)
IRAS ID
302962
Contact name
Michael Bombara
Contact email
Sponsor organisation
Rallybio IPA, LLC
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
The goal of this study is to assess the risk for a rare condition known as foetal and neonatal alloimmune thrombocytopenia (FNAIT). FNAIT is a rare condition which affects a baby's platelets and puts them at risk of problems with bleeding, particularly in the brain. Platelets are blood cells that are very important in helping blood to clot. All platelets have proteins on their surface called human platelet antigens (HPAs). In babies, half of these proteins are inherited from the mother and half from the father. In FNAIT, the mother’s immune system recognises the baby’s HPAs inherited from the father as foreign and develops antibodies against them. This process is called HPA-1a alloimmunisation. The antibodies can cross the placenta and attack the baby’s platelets. If this happens, the baby’s platelets may be destroyed, causing the baby’s platelet count to fall to a dangerously low level. This can have serious effects on the baby’s health.
In this study, we will collect data which includes laboratory results, history of FNAIT and other demographic information from study participants about HPA-1a alloimmunisation and the outcome of pregnancy from women who are found to be at higher risk of FNAIT. We will also collect data about occurrence of low platelet counts (thrombocytopenia) in infants born to these women.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0156
Date of REC Opinion
6 Sep 2021
REC opinion
Further Information Favourable Opinion