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Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

Last updated on October 12, 2019

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Study Location
Contact
1-800-718-1021
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 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

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.

NCT00244114
Pfizer
Completed
Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients

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Descriptive Information
Brief TitleStudy Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
Official TitleIn 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 SummaryBased 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 DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
ConditionHemophilia 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 StatusCompleted
Actual Enrollment
 (submitted: June 1, 2010)
20
Original Enrollment
 (submitted: October 24, 2005)
18
Actual Study Completion DateDecember 2009
Actual Primary Completion DateDecember 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
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location CountriesCanada,   Finland,   France,   Germany,   United Kingdom,   United States
 
Administrative Information
NCT NumberNCT00244114
Other Study ID Numbers3090A1-900
B1821003; 3090A-101795
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyWyeth is now a wholly owned subsidiary of Pfizer
Study SponsorWyeth is now a wholly owned subsidiary of Pfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateFebruary 2013

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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