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Observational Study for Hemophilia A in Mothers and Children

This is an observational study called HARP (Hemophilia A Research Program) that looks at hemophilia A in pregnant mothers and their children. It aims to understand the risks of bleeding during and after pregnancy for mothers with a severe hemophilia A genotype (a specific genetic makeup). For children, the study wants to learn about the risks, timing, and reasons for developing antibodies against Factor VIII (FVIII), which is a protein needed for blood clotting and is missing or low in people with hemophilia A. The study will follow mother-child pairs from pregnancy until the child with severe hemophilia A is at least 2 years old. You might be able to join if you are pregnant, before 37 weeks, and are known to have or are at risk of having a severe hemophilia A genotype, and your baby is also at risk.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any specific treatments. It plans to enroll about 500 participants, including approximately 120 pregnant mothers.
What's involved
Participants will be followed from pregnancy until the child with severe hemophilia A is at least 2 years old, or longer if possible. Your healthcare providers will continue to manage your care.
Compensation
Not stated in the trial record.
Follow-up
Mother-child pairs will be followed 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, and they will be followed for as long as feasible.

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NCT07414511

Hemophilia A Research Program

Recruiting
Not specifiedAll AgesObservational
University of Washington
~500 participants
Updated 2026-02-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint(s)/Outcome(s)
Measured over 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.

Conditions

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

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Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Jill M Johnsen, MD · PRINCIPAL_INVESTIGATOR · University of Washington
  • Grier Page, PhD · PRINCIPAL_INVESTIGATOR · RTI International
  • Shannon Meeks, MD · PRINCIPAL_INVESTIGATOR · Emory University

Who to contact

Jill M Johnsen, MD
[email protected]
206 568-2230
Email the study team

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Eligibility criteria

Inclusion

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
The pregnant mother has a severe hemophilia A genotype.
A fetus is determined to have a \>/= 25% risk of inheriting severe hemophilia A, or prenatal testing indicates a fetus is affected by severe hemophilia A.
No other discontinuation criteria have been identified.
Severe hemophilia A defined by a baseline FVIII:C \< 0.01 IU/mL (or FVIII:C \< 1%) or a genotype predicted to cause severe hemophilia A
Born to a mother participating in the study
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

Exclusion

Genetic testing is negative for a severe hemophilia A genotype
Prenatal clinical diagnostic testing that indicates there is no fetus affected with severe hemophilia A
Presence of another clinically significant bleeding disorder
Participation in another study for which any blood collection total would exceed safety limits defined in this study
Will deliver outside the United States or plans for regular pediatric care for the child to be delivered outside the United States
Is a prisoner
Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study
Inability for study team to obtain translated study documents in time for participation if participant is not fluent in English
Infant does not have severe hemophilia A defined by a baseline FVIII:C \< 0.01 IU/mL (or FVIII:C \< 1%) or does not have a genotype predicted to cause severe hemophilia A
Mother or child did not have minimal required study samples or data collected before birth, around the time of delivery, or in the neonatal period
Child has another clinically significant bleeding disorder
Child has a clinically severe immune disorder
Participation in another study for which any blood collection total would exceed safety limits defined in this study
Any other reason that, in the opinion of the investigator, would render the individual unsuitable for participation in the study

What this trial measures

  • Primary Endpoint(s)/Outcome(s)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.

    The study primary endpoints/outcomes for the maternal and pediatric cohorts are as follows: • Maternal: Rates of primary PPH, defined as * estimated or quantified blood loss \> 1,000 mL in the first 24 hours PP, or * unplanned transfusion of blood products related to blood loss in the first 24 hours PP. As a subset of primary PPH, severe primary PPH is defined as * estimated or quantified blood loss \> 1,500 mL or requirement of \> 2 units packed red blood cells within 24 hours PP, or * primary PPH with estimated or quantified blood loss \> 1,000 mL and evidence of maternal hemodynamic instability (tachycardia, hypotension) or end organ damage with no other etiology (oliguria, creatinine \> 0.8, etc.). • Pediatric: Rate of development of humoral immune response to FVIII and proportion that progress to clinical inhibitors, defined as * clinical FVIII inhibitor, or * detection of an antibody specific to FVIII.