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ID07414511

Hemophilia A Research Program (HARP): An Observational Intergenerational Cohort Study of Hemophilia A and Factor VIII Immunogenicity

Led by University of Washington · Updated on 2026-02-17

500

Participants Needed

1

Research Sites

N/A

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 research aims to observe mother-child pairs affected by hemophilia A, focusing on severe hemophilia A cases from pregnancy through early childhood. The study seeks to understand risks for bleeding during pregnancy and postpartum in mothers with severe hemophilia A, as well as the development of antibodies against factor VIII (anti-FVIII) in their children. It also evaluates genetic and environmental factors influencing bleeding and immune responses, including data from blood relatives. The study is a national, prospective, observational cohort conducted mostly through decentralized methods and one hybrid site. It plans to enroll approximately 120 pregnant mothers at risk of severe hemophilia A and follow about 50 mother-child pairs through at least the first 2 years of the child's life. Biological samples such as blood, saliva, and others will be collected at multiple time points during pregnancy, delivery, and early childhood. Blood relatives of the child may also participate to provide additional genetic data. Participants will provide medical records, complete questionnaires, and submit biological samples longitudinally. Mothers will track bleeding and medical events, while children will have blood drawn at scheduled intervals to monitor immune development and factor VIII inhibitor formation. Data collection includes health records, patient-reported outcomes, and environmental information to support future research. Participation may last from 2.2 to 5 years, ending when the child reaches a set exposure to factor VIII or the study concludes.

CONDITIONS

Brief Title

Hemophilia A Research Program

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently pregnant and prior to 37 weeks gestation
  • Known 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
  • For pediatric continuation: child born to a participating mother with severe hemophilia A defined by baseline FVIII activity <0.01 IU/mL or genotype predicted to cause severe hemophilia A
  • First- and second-degree blood relatives of the child, or other blood relatives informative for genetic studies, may be eligible
Not Eligible

You will not qualify if you...

  • Genetic testing negative for severe hemophilia A genotype in mother
  • Prenatal testing shows fetus is not affected by severe hemophilia A
  • Presence of another clinically significant bleeding disorder
  • Participation in another study exceeding blood collection safety limits
  • Planning delivery or regular pediatric care outside the United States
  • Prisoner status
  • Inability to obtain translated study documents if not fluent in English
  • For child: absence of required samples or data before birth or neonatal period
  • Child has another significant bleeding disorder or severe immune disorder
  • Any other investigator-determined reason making participation unsuitable or unsafe

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) to confirm eligibility during pregnancy

Surveillance

Duration - Approximately 2 to 5 years depending on child’s age and study continuation

Participants are observed longitudinally from enrollment during pregnancy through at least the child’s first 2 years of life to collect biological samples and health data.

Multiple visits including blood sample collections timed with clinical procedures, questionnaires, and diary entries; frequency varies with pregnancy stage and child’s development

Trial Site Locations

Total: 1 location

1

University of Washington

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

J

Jill M Johnsen, MD

G

G Shellye Horowitz, MA

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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Published Research Related To This Trial

Evaluation of the self-administered bleeding assessment tool (Self-BAT) in haemophilia carriers and correlations with quality of life.

J E Young, J Grabell, A Tuttle...

https://pubmed.ncbi.nlm.nih.gov/28949433

Generation and optimization of the self-administered bleeding assessment tool and its validation as a screening test for von Willebrand disease.

M Deforest, J Grabell, S Albert...

https://pubmed.ncbi.nlm.nih.gov/26179127

Early origins of inflammation: An examination of prenatal and childhood social adversity in a prospective cohort study.

Natalie Slopen, Eric B Loucks, Allison A Appleton...

https://pubmed.ncbi.nlm.nih.gov/25462912