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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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1 May 2012 |
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Main ID: |
EUCTR2004-002648-88-FR |
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Date of registration:
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05/10/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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)
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Scientific title:
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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)
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Date of first enrolment:
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29/09/2009 |
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Target sample size:
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18 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002648-88 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Control group of haemophilia B patients
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Control group of haemophilia B patients
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Phase:
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Countries of recruitment
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France
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Study Group:
1. Written informed consent or assent, as applicable.
2. 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 (subjects with no known history of class ll or class lll allergic reactions to any FIX product):
1. Written informed consent or assent, as applicable.
2. Subjects with moderate to severe hemophilia B (FIX: C <5%).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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 have 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 (subjects with no known history of class ll or class lll allergic reactions to any FIX product):
1. Subjects with documented evidence of prior class ll or class lll allergic reaction to any FIX product.
2. Subjects with documented evidence of prior or current FIX inhibitor
3. (BU = 0.6)
4. Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
5. Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).
6. Subjects unable to comply with a minimum 5-day FIX washout requirement.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Haemophilia B
MedDRA version: 9.1
Level: LLT
Classification code 10018939
Term: Haemophilia B (Factor IX)
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Intervention(s)
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Pharmaceutical Form:
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Primary Outcome(s)
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Primary end point(s): Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups.
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Secondary Objective: N/A
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Main Objective: 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.
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Secondary ID(s)
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2004-002648-88-GB
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3090A-101795-WW / 3090A1-900-WW
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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