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ATHN 8: Previously Untreated Patients (PUPs) Matter Study

NCT03818529 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Hemophilia
  • Hemophilia A
  • Hemophilia B
  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor
  • Haemophilia B Without Inhibitor
  • Haemophilia A Without Inhibitor
  • Haemophilia

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Octapharma

    collaborator INDUSTRY

  • Takeda

    collaborator INDUSTRY

  • American Thrombosis and Hemostasis Network

    lead NETWORK

Principal Investigators

  • Shannon Carpenter, MD, MS · Children's Mercy Hospital Kansas City

  • Courtney Thornburg, MD, MS · University of California San Diego, Rady Children's Hospital San Diego

  • Marijke van den Berg, MD, PhD · Versiti

Eligibility

Min Age
0 Years
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2022-01-26
Completion
2022-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818529 on ClinicalTrials.gov