Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
NCT00244114
ABOUT THIS STUDY
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Study Group:
- Written informed consent or assent, as applicable.
- Subjects with moderate to severe Hemophilia B (FIX:C <5%), who have reported class II or class III allergic manifestations within 24 hours of a BeneFIX infusion.
Control Group:
- Written informed consent or assent, as applicable.
- Subjects with moderate to severe Hemophilia B (FIX:C <5%)
Study group:
- Subjects who had no reaction when rechallenged with BeneFIX, in the absence of
prophylactic immunomodulating therapy.
- Subjects whose most recent allergic manifestations with BeneFIX occurred >36 months
prior to providing written informed consent for this study.
- Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy
within 72 hours of the scheduled visit for this study.
- Subjects with immune disorders.
- Subjects unable to comply with a minimum 5-day FIX washout requirement.
Control group:
- Subjects with documented evidence of prior allergic reaction to any FIX product.
- Subjects with documented evidence of prior or current FIX inhibitor (BU >0.6).
- Subjects have taken antihistamine, steroidal, or other immunosuppressive therapy
within 72 hours of the scheduled study blood draw.
- Subjects with immune disorder.
- Subjects unable to comply with a minimum 5-day FIX washout requirement.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients | |||
Official Title | In Vitro Evaluation Of Allergic Reactions In Hemophilia B Subjects Who Have Exhibited A Systemic Allergic Response After Exposure To BeneFIX (Nonacog Alfa; Recombinant Factor IX) | |||
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 Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Not Provided | |||
Study Population | Not Provided | |||
Condition | Hemophilia B | |||
Intervention |
| |||
Study Groups/Cohorts |
| |||
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 | |||
Actual Enrollment | 20 | |||
Original Enrollment | 18 | |||
Actual Study Completion Date | December 2009 | |||
Actual Primary Completion Date | December 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: Study Group:
Control Group:
Exclusion Criteria: Study group:
Control group:
| |||
Sex/Gender |
| |||
Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | Canada, Finland, France, Germany, United Kingdom, United States | |||
Administrative Information | ||||
NCT Number | NCT00244114 | |||
Other Study ID Numbers | 3090A1-900 B1821003; 3090A-101795 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 |