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Clotting Factor Replacement Product

Treatment for Hemophilia

N/A
Waitlist Available
Led By Shannon Carpenter, MD, MS
Research Sponsored by American Thrombosis and Hemostasis Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

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.

Eligible Conditions
  • Hemophilia
  • Hemophilia A
  • Hemophilia B

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine percentage of patients with confirmed inhibitors
Secondary outcome measures
Determine mean age of diagnosis and first exposure to factor treatment product
Determine percentage of eligible participants enrolled at each site
Determine risk factors including genetic variants associated with inhibitor development in PUPs
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Who is running the clinical trial?

American Thrombosis and Hemostasis NetworkLead Sponsor
9 Previous Clinical Trials
4,256 Total Patients Enrolled
2 Trials studying Hemophilia
3,310 Patients Enrolled for Hemophilia
CSL BehringIndustry Sponsor
197 Previous Clinical Trials
1,211,129 Total Patients Enrolled
3 Trials studying Hemophilia
3,382 Patients Enrolled for Hemophilia
TakedaIndustry Sponsor
1,227 Previous Clinical Trials
4,222,268 Total Patients Enrolled
2 Trials studying Hemophilia
74 Patients Enrolled for Hemophilia
~34 spots leftby Sep 2025
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