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Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00195221
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.


Condition or disease
Hemophilia B Allergic Reactions

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Study Type : Observational
Enrollment : 166 participants
Time Perspective: Retrospective
Official Title: A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B
Study Start Date : February 2005
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00195221


Locations
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United States, Arizona
Phoenix, Arizona, United States, 85016
United States, California
Orange, California, United States, 92868
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Idaho
Boise, Idaho, United States, 83712
United States, Illinois
Peoria, Illinois, United States, 61614
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Michigan
East Lansing, Michigan, United States, 48823
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Ohio
Dayton, Ohio, United States, 45404-1815
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Memphis, Tennessee, United States, 38105
United States, Texas
Fort Worth, Texas, United States, 76104
San Antonio, Texas, United States, 78207
United States, Washington
Seattle, Washington, United States, 98105
Austria
Vienna, Austria, 1090
Belgium
Brussels, Belgium
Montegnee, Belgium, 4420
Canada, Alberta
Calgary, Alberta, Canada, T2N2T9
France
Liffre, France, 35340
Montmorency, France, 95160
Paris, France, 75014
Strasbourg, France, 67098
Germany
Hamburg, Germany, HH20246
Muenster, Germany, D-48413
Italy
Catania, Italy, 95124
Catanzaro, Italy, 88100
Milano, Italy, 20162
Naples, Italy, 5-80131
Padova, Italy, 35128
Palermo, Italy, 90100
Parma, Italy, 43100
Perugia, Italy, 06100
Vicenza, Italy, 36100
Spain
Valencia, Spain, 46009
Valladolid, Spain, 47004
United Kingdom
Wolverhampton, Wstmid, United Kingdom, WV10 0QP
Cardiff, United Kingdom, CF14 4XN
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
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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
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ClinicalTrials.gov Identifier: NCT00195221    
Other Study ID Numbers: 3090A-101657
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hemophilia B
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Hypersensitivity
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Immune System Diseases