Status:
COMPLETED
Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Hemophilia B
Eligibility:
All Genders
13-65 years
Brief Summary
This 6-month prospective outcomes study addresses the association between timing of infusion, patient activity levels, and bleeding episodes through patient-reported measurements.
Eligibility Criteria
Inclusion
- 13 to 65 years old at the time of screening
- has moderately severe or severe hemophilia A or B (FVIII/FIX level
- ≤2%), with or without transient inhibitors
- Hemophilia A patient currently prescribed ADVATE (FVIII) or Hemophilia B patient currently prescribed RIXUBIS (FIX)
- previously treated with plasma-derived FVIII/FIX concentrates or recombinant FVIII/FIX for ≥150 documented exposure days (EDs)
- is willing and able to comply with the requirements of the protocol
- is proficient in the English language to allow for use of the SPACE eDiary
Exclusion
- inhibitor titer ≥0.6 Bethesda units or currently being treated for an inhibitor
- has participated in another clinical study involving a medicinal product or device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving a medicinal product or device during the course of this study
- is a family member or employee of the investigator
- elective major surgery is planned within 6 months after enrollment which may interfere with activities of daily living (at investigator's discretion)
- continuously require walking assistance devices (eg, wheelchair, crutches, etc.)
Key Trial Info
Start Date :
July 22 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 29 2016
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT02190149
Start Date
July 22 2014
End Date
March 29 2016
Last Update
March 17 2021
Active Locations (17)
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1
Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center
Los Angeles, California, United States, 90007
2
Rady Childrens Hospital
San Diego, California, United States, 92123
3
University of Colorado
Aurora, Colorado, United States, 80045
4
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61615