Actively Recruiting
Hemophilia A Research Program
Led by University of Washington · Updated on 2026-02-17
500
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hemophilia A Research Program
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Pregnant mother has a severe hemophilia A genotype before 38 weeks of pregnancy
- Fetus has at least a 25% risk of inheriting severe hemophilia A or prenatal testing shows severe hemophilia A
- Child has severe hemophilia A defined by baseline FVIII:C < 0.01 IU/mL or genotype predicted to cause severe hemophilia A
- Child is born to a mother participating in the study
- Blood relatives of the child including first- and second-degree relatives or others whose data may help genetic studies may be included
You will not qualify if you...
- Genetic testing negative for severe hemophilia A genotype in the pregnant mother
- Prenatal testing indicates no fetus affected with severe hemophilia A
- Presence of another clinically significant bleeding disorder
- Participation in another study exceeding blood collection safety limits
- Planned delivery or regular pediatric care outside the United States
- Prisoner status
- Inability to obtain translated study documents if not fluent in English
- Infant does not have severe hemophilia A by baseline FVIII:C or genotype
- Mother or child lack required study samples or data around birth or neonatal period
- Child has another clinically significant bleeding disorder or severe immune disorder
- Investigator determines unsuitability for participation for any reason
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Washington
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
J
Jill M Johnsen, MD
CONTACT
G
G Shellye Horowitz, MA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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