ClinicalTrials.Veeva

Menu

Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Wyeth logo

Wyeth

Status

Completed

Conditions

Hemophilia B

Treatments

Procedure: Blood draw
Drug: blood draw

Study type

Observational

Funder types

Industry

Identifiers

NCT00244114
B1821003 3090A-101795;
3090A1-900

Details and patient eligibility

About

Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.

Enrollment

20 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Study Group:

  • Written informed consent or assent, as applicable.
  • 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:

  • Written informed consent or assent, as applicable.
  • Subjects with moderate to severe Hemophilia B (FIX:C <5%)

Exclusion criteria

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.

Trial design

20 participants in 2 patient groups

A
Treatment:
Drug: blood draw
B
Treatment:
Procedure: Blood draw

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems