Study of Prophylaxis, ACtivity and Effectiveness (SPACE) in Hemophilia Patients Currently Treated With ADVATE or RIXUBIS



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:13 - 65
Updated:10/25/2017
Start Date:July 2014
End Date:March 2016

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This 6-month prospective outcomes study addresses the association between timing of infusion,
patient activity levels, and bleeding episodes through patient-reported measurements.


Inclusion Criteria:

- 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 Criteria:

- 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.)
We found this trial at
17
sites
200 Hawthorne Ln
Charlotte, North Carolina 28204
(704) 384-4000
Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming a new era in...
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740 South Limestone Street
Lexington, Kentucky 40536
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Lexington, KY
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Aurora, Colorado 80045
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Aurora, CO
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Baltimore, MD
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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East Lansing, Michigan 48824
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East Lansing, MI
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Great Neck, New York 11021
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Great Neck, NY
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Harlingen, Texas 78550
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Harlingen, TX
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Kansas City, Missouri 64108
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Kansas City, MO
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Los Angeles, CA
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Nashville, Tennessee 37232
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Peoria, IL
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San Diego, California 92123
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Seattle, Washington 98104
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Seattle, WA
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105 Sixth St
Traverse City, Michigan 49684
(231) 935-5000
Munson Medical Center There’s no place quite like northern Michigan, and there is no other...
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Traverse City, MI
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