Status:
RECRUITING
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Lead Sponsor:
American Thrombosis and Hemostasis Network
Collaborating Sponsors:
Pfizer
Hemophilia of Georgia, Inc.
Conditions:
Hematologic Disorder
Bleeding Disorder
Eligibility:
All Genders
Brief Summary
In parallel with the growth of ATHN's clinical studies, the number of new therapies for all blood disorders is increasing significantly. Some of the recently FDA-approved therapies for congenital and ...
Detailed Description
This is a longitudinal, natural history observational cohort study being conducted at approximately 150 ATHN-affiliated sites with a target accrual of 3,000 participants. Participants will be followed...
Eligibility Criteria
Inclusion
- Participants who meet the following inclusion criteria and none of the exclusion criteria are eligible for enrollment in one of the open disease-specific arms.
- Any age
- Having a congenital or acquired blood disorder; or
- Having a bleeding phenotype as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score with an unknown diagnosis; or
- Connective tissue disorder with bleeding tendency as indicated by an age adjusted abnormal ISTH Bleeding Assessment Tool score.
- Eligible for a currently active disease-specific arm.
- Concurrent enrollment in the ATHNdataset or current ATHNdataset participant.
Exclusion
- 1\. Does not qualify for inclusion in a currently activedisease-specific arm; participants may be eligible to enroll as future cohorts and arms are activated; 2. Unable to give informed consent or assent 3. Unwilling to perform study procedures
- Cohort Participant Selection
- Each participant is to be enrolled in the cohort for which they qualify as defined below.
- Hemophilia Cohort
- Inclusion Criteria:
- Participants who meet any of the following inclusion criteria are eligible for enrollment into this cohort:
- Factor VIII or factor IX activity \<50%, without another explanation for low clotting factor other than congenital hemophilia or being a known carrier for congenital hemophilia; OR
- Carrier for congenital hemophilia with a factor VIII \>=50% or factor IX activity \>=50% with or without a bleeding phenotype as indicated by an ISTH Bleeding Assessment Tool score of ≥4 for adult males, ≥6 for adult females, or ≥3 for children younger than 18 years OR
- Known congenital hemophilia that have a factor level \>50% after receiving vector, OR 4. Acquired hemophilia.
Key Trial Info
Start Date :
September 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2035
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT04398628
Start Date
September 30 2020
End Date
December 1 2035
Last Update
December 15 2025
Active Locations (72)
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1
Arizona Hemophilia and Thrombosis Treatment Center at Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, United States, 72202
3
Orthopaedic Institute for Children HTC
Los Angeles, California, United States, 90007
4
Childrens Hospital Los Angeles
Los Angeles, California, United States, 90027-6016