Status:
COMPLETED
Joint Health Study
Lead Sponsor:
Bloodworks
Collaborating Sponsors:
CSL Behring
Conditions:
Hemophilia B
Eligibility:
MALE
16+ years
Brief Summary
This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the stan...
Detailed Description
This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the stan...
Eligibility Criteria
Inclusion
- Severe hemophilia B (FIX \<1%)
- Either on demand or on prophylaxis with rFIX or EHL-rIX products with the intention to stay on the current regimen for the next 3 years
- For Group C, start of this treatment regimen up to 6 months prior is permissible
Exclusion
- Other known bleeding disorder
- Other rheumatologic disorder affecting joints
- Other known neuromotor defect (making physical exam difficult)
Key Trial Info
Start Date :
November 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 17 2020
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03358836
Start Date
November 15 2017
End Date
August 17 2020
Last Update
June 22 2022
Active Locations (5)
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1
Orthopaedic Institute for Children at University of California Los Angeles
Los Angeles, California, United States, 90007
2
University of California San Diego
San Diego, California, United States, 92122
3
Tulane University
New Orleans, Louisiana, United States, 70112
4
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098