Status:
COMPLETED
ATHN 8: Previously Untreated Patients (PUPs) Matter Study
Lead Sponsor:
American Thrombosis and Hemostasis Network
Collaborating Sponsors:
CSL Behring
Octapharma
Conditions:
Hemophilia
Hemophilia A
Eligibility:
All Genders
Up to 13 years
Brief 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 Cent...
Detailed Description
This multi-center, longitudinal, observational, prospective and retrospective study of previously untreated patients (PUPs) with moderate to severe hemophilia A or B during the initial 50 exposure day...
Eligibility Criteria
Inclusion
- 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
- Patients who are referred to the HTC with no record of bleed and factor utilization data
Key Trial Info
Start Date :
October 3 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
237 Patients enrolled
Trial Details
Trial ID
NCT03818529
Start Date
October 3 2018
End Date
December 31 2022
Last Update
February 1 2023
Active Locations (27)
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1
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Valley Children's Hospital
Madera, California, United States, 93636
3
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
4
UCSF Pediatric Hemophilia Treatment Center at Mission Bay
San Francisco, California, United States, 94158