Clinical Trial: Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: In Vitro Evaluation Of Allergic Reactions In Hemophilia B Subjects Who Have Exhibited A Systemic Allergic Response After Exposure To BeneFIX (
Brief Summary: Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.
Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups [ Time Frame: within 36 months after allergic reaction ]
Original Primary Outcome: Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
Current Secondary Outcome:
- Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected [ Time Frame: 15 days ]
- Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported. [ Time Frame: 15 days following study blood draw ]
Original Secondary Outcome:
- Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected
- Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: October 19, 2005
Date Started: February 2006
Date Completion:
Last Updated: February 14, 2013
Last Verified: February 2013