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) - Basophil Clinical Study

Phase 1

• Conditions: Hemophilia B

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-19
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• 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 (systemic with respiratory involvement) or class III (severe anaphylaxis with hypotension) allergic manifestations within 24 hours of a BeneFIX infusion.
Control Group:
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 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:
1. Subjects with documented evidence of prior class II or class III allergic reaction to any FIX product.
2. Subjects with documeted evidence of prior or current FIX inhibitor (BU > or = to 0.6).
3. Subjects who have taken antihistimine, steroidal, or other immunosuppresive therapy within 72 hours of the scheduled study visit.
4. Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).
5. 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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary: Describe the histamine release patterns produced by activated basophils obtained from peripheral blood of subjects who meet the protocol entry criteria, using the methodology described in the protocol.;Secondary Objective: N/A;Primary end point(s): Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups.