Hemophilia A Research Program

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT07414511
Status
Recruiting
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Conditions

  • Alloimmunization
  • Bleeding Disorder
  • Carrier of Hemophilia A
  • FVIII Deficiency
  • Factor VIII (FVIII)
  • Hemophilia A
  • Hemophilia A, Severe
  • Hemorrhage, Postpartum
  • Inhibitors
  • Maternal Blood Loss
  • Pregnancy
  • Pregnancy Complications
  • X-Linked

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jul 31, 2024
Status verified
Feb 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Maternal Cohort
    Inclusion Criteria (mother): * Currently pregnant and prior to 37 weeks gestation * Known or at-risk of having a severe hemophilia A genotype * Pregnant with a fetus at-risk of inheriting severe hemophilia A * Ability to understand and willingness to provide informed consent * 18 years of age or older
  • Arm: Pediatric Cohort Continuation Criteria (Child)
    * Severe hemophilia A defined by a baseline factor VIII activity (FVIII:C) \<0.01 international units (IU)/mL (or FVIII:C \< 1%) or a genotype predicted to result in severe hemophilia A * Born to a pregnant mother participating in the study * Absence of discontinuation criteria
  • Arm: Blood Relatives of the Child (may be offered participation)
    * First-degree blood relatives (e.g., father, sibling) of the child * Second-degree blood relatives (e.g., aunt, uncle, grandparent, half-sibling) of the child * Any more distant male or female blood relative whose data or samples may be informative for the planned genetic studies of hemophilia and inhibitors

Primary Outcome Measure

Primary Endpoint(s)/Outcome(s) [ Time Frame: For mother-child pairs, from enrollment until the child with severe hemophilia A is at least 2 years old*, or until a study discontinuation criteria is met. *This is the minimum duration, the mother-child pairs will be followed for as long as feasible. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of WashingtonSeattleWashington98109
Shellye Horowitz, MA
[email protected]
206-568-2230
Danielle Drury-Stewart, PhD
[email protected]
Jill Johnsen, MD (PRINCIPAL_INVESTIGATOR)

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