Hemophilia A Research Program (HARP): An Observational Intergenerational Cohort Study of Hemophilia A and Factor VIII Immunogenicity
University of Washington
Summary
This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood. Because the study follows mother-child pairs, the study includes both a maternal cohort and a pediatric cohort. Each cohort has a primary goal: for the mother with a severe hemophilia genotype, the overarching primary goal is to understand the risks for pregnancy-associated bleeding and postpartum hemorrhage (PPH); for the child, the overarching primary goal is to understand the risks, timing, and circumstances of development of anti-FVIII antibodies. From a longitudinal perspective, risks for both bleeding in the mother and anti-FVIII antibody development in the child are expected to be influenced over time by genetic and environmental factors that begin early in (or before) pregnancy. Enrollment of blood relatives is offered to improve power to better understand inherited contributions to bleeding and inhibitor development in the mother-baby pairs.
Description
HARP is a longitudinal observational, decentralized and multisite (with one hybrid site), national prospective cohort study in hemophilia A. Participants will be treated by their HCPs, with no limitations on medical decision-making. Hemophilia A is an inherited X-linked bleeding disorder caused by deficiency in coagulation factor VIII (FVIII). Severe hemophilia A is defined by a FVIII level \< 0.01 IU/dL (or \< 1%). A significant complication of hemophilia A is the development of immune responses to FVIII, also known as inhibitors. In pregnancy, mothers who have a hemophilia-causing genotype…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Maternal Inclusion Criteria: Pregnant individuals who meet the following criteria are eligible for enrollment as study participants: * Currently pregnant and prior to 37 weeks gestation * Known to have or at-risk of having a severe hemophilia A genotype * Pregnant with at least one fetus at-risk of inheriting severe hemophilia A * Ability to understand and willingness to provide informed consent * 18 years of age or older Before the 38th week of pregnancy, enrolled participants must meet all the following criteria to continue to remain in the study: * The pregnant mother has a severe hemop…
Location
- University of WashingtonSeattle, Washington