Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS
SPACE
1 other identifier
observational
64
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2014
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2014
CompletedFirst Posted
Study publicly available on registry
July 15, 2014
CompletedStudy Start
First participant enrolled
July 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2016
CompletedMarch 17, 2021
March 1, 2021
1.7 years
July 14, 2014
March 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Advancing the understanding of the relationship between patient physical activity levels, infusion and occurrence of bleeding episodes (BEs)
After the informed consent form is signed, retrospective data on physical activity levels, infusion and occurrence of BEs will be collected. The retrospective period will be the 6 months prior to signing the ICF.
6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
Secondary Outcomes (7)
Types of current physical activities of participants
Baseline through 6 months
Activity measurement
Baseline through 6 months
Infusion schedule for participants on prophylaxis
Baseline through 6 months
Infusion amount (either ADVATE (Hemophilia A), or RIXUBIS (Hemophilia B)
Baseline through 6 months
Occurrence of bleeding episodes (BEs)
6 months retrospectively (after the informed consent form (ICF) is signed) through 6 months
- +2 more secondary outcomes
Study Arms (2)
ADVATE (Factor VIII)
Participants will remain on their current (pre-study) treatment regimen of ADVATE throughout the study period
RIXUBIS (Factor IX)
Participants will remain on their current (pre-study) treatment regimen of RIXUBIS throughout the study period
Interventions
Eligibility Criteria
Hemophilia treatment center (HTCs) in the US will be identified and invited to enroll eligible patients in this study
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Orthopaedic Hospital DBA Orthopaedic Hemophilia Treatment Center
Los Angeles, California, 90007, United States
Rady Childrens Hospital
San Diego, California, 92123, United States
University of Colorado
Aurora, Colorado, 80045, United States
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61615, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40504, United States
Johns Hopkins University School Of Medicine
Baltimore, Maryland, 21205, United States
Childrens Hospital of Michigan
Detroit, Michigan, 48201, United States
Michigan State University
East Lansing, Michigan, 48823, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108, United States
North Shore/Long Island Jewish PRIME
Great Neck, New York, 11021, United States
The Presbyterian Hospital
Charlotte, North Carolina, 28210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
The Vanderbilt Clinic
Nashville, Tennessee, 37232, United States
The University of Texas MD Anderson
Harlingen, Texas, 78550, United States
Puget Sound Blood Center
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2014
First Posted
July 15, 2014
Study Start
July 22, 2014
Primary Completion
March 29, 2016
Study Completion
March 29, 2016
Last Updated
March 17, 2021
Record last verified: 2021-03