Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
1 other identifier
observational
166
9 countries
38
Brief Summary
Retrospective, multicenter study in patients with hemophilia B. This study will be placed at 20 to 50 hemophilia treatment centers in North America and the EU, and is designed to estimate the frequency of Class II and III allergic reactions in association with the administration of any FIX concentrate. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2005
Typical duration for all trials
38 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
Study Start
First participant enrolled
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedDecember 5, 2007
December 1, 2007
September 12, 2005
December 3, 2007
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Written consent to release patient information
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Unknown Facility
Phoenix, Arizona, 85016, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Boise, Idaho, 83712, United States
Unknown Facility
Peoria, Illinois, 61614, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
East Lansing, Michigan, 48823, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Dayton, Ohio, 45404-1815, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Memphis, Tennessee, 38105, United States
Unknown Facility
Fort Worth, Texas, 76104, United States
Unknown Facility
San Antonio, Texas, 78207, United States
Unknown Facility
Seattle, Washington, 98105, United States
Unknown Facility
Vienna, 1090, Austria
Unknown Facility
Brussels, Belgium
Unknown Facility
Montegnée, 4420, Belgium
Unknown Facility
Calgary, Alberta, T2N2T9, Canada
Unknown Facility
Liffré, 35340, France
Unknown Facility
Montmorency, 95160, France
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Paris, 75014, France
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Strasbourg, 67098, France
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Hamburg, HH20246, Germany
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Münster, D-48413, Germany
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Catania, 95124, Italy
Unknown Facility
Catanzaro, 88100, Italy
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Milan, 20162, Italy
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Naples, 5-80131, Italy
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Padua, 35128, Italy
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Palermo, 90100, Italy
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Parma, 43100, Italy
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Perugia, 06100, Italy
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Vicenza, 36100, Italy
Unknown Facility
Valencia, 46009, Spain
Unknown Facility
Valladolid, 47004, Spain
Unknown Facility
Wolverhampton, Wstmid, WV10 0QP, United Kingdom
Unknown Facility
Cardiff, CF14 4XN, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, MedInfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Austria, WPVIMED@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For UK, ukmedinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, decresg@wyeth.com
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
February 1, 2005
Study Completion
November 1, 2007
Last Updated
December 5, 2007
Record last verified: 2007-12