ATHN 8: Previously Untreated Patients (PUPs) Matter Study

Completed

Conditions studied: Hemophilia, Hemophilia A, Hemophilia B, Hemophilia A With Inhibitor, Hemophilia B With Inhibitor, Haemophilia B Without Inhibitor, Haemophilia A Without Inhibitor, Haemophilia

In brief

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.

Key facts

Study ID

NCT03818529

Run by

American Thrombosis and Hemostasis Network

People needed

237

Starts

2018-10-03

Expected to finish

2022-12-31

Last updated by the study team

2023-02-01

Who can join

Age: any, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients who are referred to the HTC with no record of bleed and factor utilization data

Where it is running

• Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital — Phoenix, Arizona, United States
• Valley Children's Hospital — Madera, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• UCSF Pediatric Hemophilia Treatment Center at Mission Bay — San Francisco, California, United States
• University of Colorado Denver Hemophilia and Thrombosis Center — Aurora, Colorado, United States
• Connecticut Bleeding and Clotting Disorders Center — Farmington, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta/Emory — Atlanta, Georgia, United States
• Augusta University Hemophilia Treatment Center — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana Hemophilia and Thrombosis Center (IHTC) — Indianapolis, Indiana, United States
• Kansas City Regional Hemophilia Center — Kansas City, Kansas, United States
• Maine Hemophilia and Thrombosis Center — Scarborough, Maine, United States
• Boston Hemophilia Center at Children's Hospital of Boston — Boston, Massachusetts, United States
• University of Michigan Hemophilia and Coagulation Disorders — Ann Arbor, Michigan, United States
• Mayo Comprehensive Hemophilia Center — Rochester, Minnesota, United States
• Cincinnati Children's Hospital Medical Center, Hemophilia & Thrombosis Center — Cincinnati, Ohio, United States
• UHHS Cleveland — Cleveland, Ohio, United States
• Northwest Ohio Hemophilia Treatment Center at the Toledo Hospital — Toledo, Ohio, United States
• Oklahoma Center for Bleeding and Clotting Disorders — Oklahoma City, Oklahoma, United States
• Oregon Health and Science University — Portland, Oregon, United States
• St Jude Children's Research Hospital — Memphis, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Utah Center for Bleeding & Clotting Disorders at Primary Children's Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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