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)

Wyeth Pharmaceuticals0 个研究点目标入组 18 人开始时间: 2009年10月5日最近更新: 2012年5月1日

研究概览

暂无简介。

•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

•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.

发起方

Wyeth Pharmaceuticals