Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

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NCT00244114

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1-800-718-1021
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Advanced Information
Descriptive Information
Brief Title Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
Official Title 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)
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Hemophilia B
Intervention
  • Drug: blood draw
    Single blood sample collected to perform histamine release assay.
  • Procedure: Blood draw
    Single blood sample collected to perform histamine release assay.
Study Groups/Cohorts
  • A
    Intervention: Drug: blood draw
  • B
    Intervention: Procedure: Blood draw
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 1, 2010)		20
Original Enrollment
 (submitted: October 24, 2005)		18
Actual Study Completion Date December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada,   Finland,   France,   Germany,   United Kingdom,   United States
 
Administrative Information
NCT Number NCT00244114
Other Study ID Numbers 3090A1-900
B1821003; 3090A-101795
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date February 2013