Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
NCT ID: NCT02190149
Last Updated: 2021-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
64 participants
OBSERVATIONAL
2014-07-22
2016-03-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ADVATE (Factor VIII)
Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period
ADVATE (Antihemophilic Factor [Recombinant])
RIXUBIS (Factor IX)
Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period
RIXUBIS (Coagulation Factor IX [Recombinant])
Interventions
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ADVATE (Antihemophilic Factor [Recombinant])
RIXUBIS (Coagulation Factor IX [Recombinant])
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.)
13 Years
65 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center
Los Angeles, California, United States
Rady Childrens Hospital
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, United States
Childrens Hospital of Michigan
Detroit, Michigan, United States
Michigan State University
East Lansing, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, United States
North Shore/Long Island Jewish PRIME
Great Neck, New York, United States
The Presbyterian Hospital
Charlotte, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
The Vanderbilt Clinic
Nashville, Tennessee, United States
The University of Texas MD Anderson
Harlingen, Texas, United States
Puget Sound Blood Center
Seattle, Washington, United States
Countries
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Related Links
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To obtain more information on the study, click here/on this link.
Other Identifiers
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061302
Identifier Type: -
Identifier Source: org_study_id
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