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Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Study Group:

- Written informed consent or assent, as applicable.

- Subjects with moderate to severe Hemophilia B (FIX:C 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT00244114
Pfizer
Completed
Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

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