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)

• Conditions: Haemophilia B; MedDRA version: 9.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)

• Registration Number: EUCTR2004-002648-88-FR
• Lead Sponsor: Wyeth Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-05
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Study Group:
1. Written informed consent or assent, as applicable.
2. 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 (subjects with no known history of class ll or class lll allergic reactions to any FIX product):
1. Written informed consent or assent, as applicable.
2. Subjects with moderate to severe hemophilia B (FIX: C <5%).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Study Group:
1. Subjects who had NO reaction when rechallenged with BeneFIX, in the absence of
prophylactic immunomodulating therapy.
2. Subjects whose most recent allergic manifestations with BeneFIX have occurred > 36 months prior to providing written consent for this study.
3. Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
4. Subjects with immune disorders (e.g. HIV, myeloma, lymphoma).
5. Subjects unable to comply with a minimum 5-day FIX washout requirement.

Control Group (subjects with no known history of class ll or class lll allergic reactions to any FIX product):
1. Subjects with documented evidence of prior class ll or class lll allergic reaction to any FIX product.
2. Subjects with documented evidence of prior or current FIX inhibitor
3. (BU = 0.6)
4. Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
5. Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).
6. Subjects unable to comply with a minimum 5-day FIX washout requirement.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified