Hemophilia A Research Program HARP Observing Mother-Child Pairs to Understand Severe Hemophilia A and Immune Response During Pregnancy and Early Childhood

What this Trial Is About

This research aims to observe mother-child pairs affected by hemophilia A, focusing on severe hemophilia A cases from pregnancy through early childhood. The study seeks to understand risks for bleeding during pregnancy and postpartum in mothers with severe hemophilia A, as well as the development of antibodies against factor VIII anti-FVIII in their children. It also evaluates genetic and environmental factors influencing bleeding and immune responses, including data from blood relatives. The study is a national, prospective, observational cohort conducted mostly through decentralized methods and one hybrid site. It plans to enroll approximately 120 pregnant mothers at risk of severe hemophilia A and follow about 50 mother-child pairs through at least the first 2 years of the childs life. Biological samples such as blood, saliva, and others will be collected at multiple time points during pregnancy, delivery, and early childhood. Blood relatives of the child may also participate to provide additional genetic data. Participants will provide medical records, complete questionnaires, and submit biological samples longitudinally. Mothers will track bleeding and medical events, while children will have blood drawn at scheduled intervals to monitor immune development and factor VIII inhibitor formation. Data collection includes health records, patient-reported outcomes, and environmental information to support future research. Participation may last from 2.2 to 5 years, ending when the child reaches a set exposure to factor VIII or the study concludes.

Hemophilia A Research Program