Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
NCT ID: NCT00195221
Last Updated: 2007-12-05
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
166 participants
OBSERVATIONAL
2005-02-28
2007-11-30
Brief Summary
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Following informed consent and eligibility, historical patient information including demographics, allergy history, hemophilia history, frequency and severity of allergic reaction(s), number of exposure days with products causing allergic reactions, exposure days to blood products including FIX concentrates, treatment for allergic reaction(s), outcome of event(s), any other adverse event(s) occuring within 48 hours of onset of allergic reaction(s), rechallenge and outcome, switch to another FIX product (if applicable) and outcome, current status of patient, and results of any special studies (eg, skin or RAST testing, alloantibody analyses, ect) will be collected.
Detailed Description
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Conditions
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Keywords
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Study Design
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RETROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Living or deceased patients with mild to severe hemophilia B who have had at least 1 exposure to replacement factor IX product(s).
* Living or deceased patients who had their first infusion of any FIX product between 1 January 1991 and 31 December 2003.
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Phoenix, Arizona, United States
Orange, California, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Peoria, Illinois, United States
Iowa City, Iowa, United States
East Lansing, Michigan, United States
Rochester, Minnesota, United States
New Brunswick, New Jersey, United States
Dayton, Ohio, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Vienna, , Austria
Brussels, , Belgium
Montegnée, , Belgium
Calgary, Alberta, Canada
Liffré, , France
Montmorency, , France
Paris, , France
Strasbourg, , France
Hamburg, , Germany
Münster, , Germany
Catania, , Italy
Catanzaro, , Italy
Milan, , Italy
Naples, , Italy
Padua, , Italy
Palermo, , Italy
Parma, , Italy
Perugia, , Italy
Vicenza, , Italy
Valencia, , Spain
Valladolid, , Spain
Wolverhampton, Wstmid, United Kingdom
Cardiff, , United Kingdom
Countries
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Other Identifiers
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3090A-101657
Identifier Type: -
Identifier Source: org_study_id