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

Completed

Conditions studied: Hemophilia A, Hemophilia B

In brief

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

Key facts

Study ID

NCT02190149

Run by

Baxalta now part of Shire

People needed

64

Starts

2014-07-22

Expected to finish

2016-03-29

Last updated by the study team

2021-03-17

Who can join

Age: 13 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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.)

Where it is running

• 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

Full record on ClinicalTrials.gov

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