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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002648-88-GB
Enrollment
18
Registered
2005-04-19
Start date
2005-11-17
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia B

Interventions

Trade Name: BeneFIX Product Name: BeneFIX Product Code: 3090 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Nonacog alfa Current Sponsor code: 3090 Other descr

Sponsors

Wyeth Pharmaceuticals
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Study Group: 1. Written informed consent or assent, as applicable. 2. Subjects with moderate to severe hemophilia B (FIX: C =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

France, Germany, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026