- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00195221
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
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.
Study Overview
Status
Conditions
Study Type
Enrollment
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
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Brussels, Belgium
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Montegnee, Belgium, 4420
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Alberta
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Calgary, Alberta, Canada, T2N2T9
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Liffre, France, 35340
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Montmorency, France, 95160
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Paris, France, 75014
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Strasbourg, France, 67098
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Hamburg, Germany, HH20246
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Muenster, Germany, D-48413
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Catania, Italy, 95124
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Catanzaro, Italy, 88100
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Milano, Italy, 20162
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Naples, Italy, 5-80131
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Padova, Italy, 35128
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Palermo, Italy, 90100
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Parma, Italy, 43100
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Perugia, Italy, 06100
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Vicenza, Italy, 36100
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Valencia, Spain, 46009
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Valladolid, Spain, 47004
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Cardiff, United Kingdom, CF14 4XN
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Wstmid
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Wolverhampton, Wstmid, United Kingdom, WV10 0QP
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Arizona
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Phoenix, Arizona, United States, 85016
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California
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Orange, California, United States, 92868
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Georgia
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Atlanta, Georgia, United States, 30322
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Idaho
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Boise, Idaho, United States, 83712
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Illinois
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Peoria, Illinois, United States, 61614
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Iowa
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Iowa City, Iowa, United States, 52242
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Michigan
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East Lansing, Michigan, United States, 48823
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Minnesota
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Rochester, Minnesota, United States, 55905
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New Jersey
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New Brunswick, New Jersey, United States, 08903
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Ohio
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Dayton, Ohio, United States, 45404-1815
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
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Tennessee
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Memphis, Tennessee, United States, 38105
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Texas
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Fort Worth, Texas, United States, 76104
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San Antonio, Texas, United States, 78207
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Washington
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Seattle, Washington, United States, 98105
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There are no exclusion criteria.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Trial Manager, For Austria, WPVIMED@wyeth.com
- Principal Investigator: Trial Manager, For Italy, decresg@wyeth.com
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3090A-101657
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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