Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B
NCT00195221
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- There are no exclusion criteria.
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Descriptive Information | ||||||||||||||||
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Brief Title | Study to Describe the Allergic Reactions to Factor IX in Patients With Hemophilia B | |||||||||||||||
Official Title | A Retrospective Study to Describe the Incidence of Moderate to Severe Allergic Reactions to Factor IX in Patients With Hemophilia B | |||||||||||||||
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. | |||||||||||||||
Detailed Description | Not Provided | |||||||||||||||
Study Type | Observational | |||||||||||||||
Study Design | Time Perspective: Retrospective | |||||||||||||||
Target Follow-Up Duration | Not Provided | |||||||||||||||
Biospecimen | Not Provided | |||||||||||||||
Sampling Method | Not Provided | |||||||||||||||
Study Population | Not Provided | |||||||||||||||
Condition |
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Intervention | Not Provided | |||||||||||||||
Study Groups/Cohorts | Not Provided | |||||||||||||||
Publications * | Not Provided | |||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||
Recruitment Information | ||||||||||||||||
Recruitment Status | Completed | |||||||||||||||
Enrollment | 166 | |||||||||||||||
Original Enrollment | Same as current | |||||||||||||||
Actual Study Completion Date | November 2007 | |||||||||||||||
Primary Completion Date | Not Provided | |||||||||||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||||||||||||||
Accepts Healthy Volunteers | No | |||||||||||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||
Listed Location Countries | Austria, Belgium, Canada, France, Germany, Italy, Spain, United Kingdom, United States | |||||||||||||||
Removed Location Countries | ||||||||||||||||
Administrative Information | ||||||||||||||||
NCT Number | NCT00195221 | |||||||||||||||
Other Study ID Numbers | 3090A-101657 | |||||||||||||||
Has Data Monitoring Committee | Not Provided | |||||||||||||||
U.S. FDA-regulated Product | Not Provided | |||||||||||||||
IPD Sharing Statement | Not Provided | |||||||||||||||
Responsible Party | Not Provided | |||||||||||||||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||
Collaborators | Not Provided | |||||||||||||||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||
Verification Date | December 2007 |