Mother-and-child hemophilia A program

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a national, longitudinal observational cohort that follows mother‑child pairs from pregnancy through at least the first two years of life to examine bleeding risks in mothers and inhibitor (anti‑FVIII antibody) development in children. The study aims to enroll about 120 pregnant individuals at risk of having a child with severe hemophilia A to yield roughly 50 affected mother‑child pairs, and invites blood relatives to improve genetic analyses. Participants receive usual clinical care from their health providers while the study collects clinical data and biological samples over time. The design is decentralized and multisite with a hybrid site at the University of Washington to support remote and occasional in‑person visits.

Why it matters

Who can join: the full rules

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 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.

Pediatric Continuation / Inclusion Criteria:

Eligibility of the child to continue is assessed by age 8 weeks. Mother-child pairs in which a child meets the following criteria will remain in the study:

* 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

Thereafter, mothers and their children will continue in the study as long as no new discontinuation criteria occur.

Inclusion Criteria for Blood Relatives:

Blood relatives of the child may be offered participation if one of the following criteria are met:

* 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/Discontinuation Criteria:

Maternal: For the pregnant person, exclusion or discontinuation criteria are as follows:

* 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

Pediatric: For the child, discontinuation criteria are as follows:

* 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

Where it's running

• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Jill M Johnsen, MD — University of Washington
• Study coordinator: Jill M Johnsen, MD
• Email: jjohnsen@uw.edu
• Phone: 206 568-2230

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.