Hemophilia BNCT00244114
Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients
An observational study of Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia B
- What is being tested?
- blood draw
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%)
Who cannot join
- 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.
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- 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.
About this study
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)
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.
- Conditions
- Hemophilia B
- Being tested
- blood draw
- Keywords
- Hemophilia B, Allergic Reaction
- Medical subject headings
- Hemophilia B, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood drawDrug
Single blood sample collected to perform histamine release assay.
Blood drawProcedure or surgery
Single blood sample collected to perform histamine release assay.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: blood draw | |
| B | Not described Receives: Procedure: Blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
Measured: within 36 months after allergic reaction
Secondary outcomes (2)
Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected
Measured: 15 days
Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.
Measured: 15 days following study blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2005 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00244114
- Sponsor's protocol ID
- 3090A1-900
- Other IDs
- B1821003; 3090A-101795
- Status last verified
- Feb 2013
- First submitted
- 19 Oct 2005
- Last updated
- 18 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00244114
- Acronym / sponsor ID
- 3090A1-900
- Conditions
- Hemophilia B
- Keywords
- Hemophilia B, Allergic Reaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: blood draw |
| B | – | Procedure: Blood draw |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Written informed consent or assent, as applicable.
- Subjects with moderate to severe Hemophilia B (FIX:C <5%)
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood drawSingle blood sample collected to perform histamine release assay. | Drug | A |
| Blood drawSingle blood sample collected to perform histamine release assay. | Procedure or surgery | B |
Primary outcome
Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
Time frame: within 36 months after allergic reaction
2 secondary outcomes
Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected
Time frame: 15 days
Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.
Time frame: 15 days following study blood draw
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2013.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia B, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups (time frame: within 36 months after allergic reaction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2013.