CompletedNot Applicable

ATHN 8: Previously Untreated Patients (PUPs) Matter Study

United States237 participantsStarted 2018-10-03

Plain-language summary

This is a multi-center cohort study of approximately 250 previously untreated patients (PUPs) with congenital moderate to severe hemophilia A or B in a network of up to 50 US Hemophilia Treatment Centers (HTCs). Participants will be followed as they receive their first 50 exposure days (ED) to clotting factor replacement product, both prospectively and retrospectively. The data collected on evolving treatment practices will define the incidence and risk factors for inhibitor development during the high risk period of first 50 ED and improve the outcomes of this vulnerable population.

Who can participate

Age range0 Years – 13 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Congenital hemophilia A; FVIII \</=5% or congenital hemophilia B; FIX \</=5%; * Birth date on or after January 1, 2010; * Care established at one of the participating HTCs; * Co-enrollment in the ATHNdataset; and * Parent or authorized guardian can provide informed consent Exclusion Criteria: * Patients who are referred to the HTC with no record of bleed and factor utilization data

What they're measuring

Determine percentage of patients with confirmed inhibitors

Timeframe: 6 years

Trial details

NCT IDNCT03818529

SponsorAmerican Thrombosis and Hemostasis Network

Sponsor typeNETWORK

Study typeOBSERVATIONAL

Primary completion2022-01-26

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