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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: |
EUCTR2004-000219-24-IT |
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Date of registration:
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09/11/2009 |
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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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A multicenter study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital hemophilia A who develop de novo factor VIII inhibitorswhile receiving factor VIII infusion therapy.
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Scientific title:
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A multicenter study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital hemophilia A who develop de novo factor VIII inhibitorswhile receiving factor VIII infusion therapy. |
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Date of first enrolment:
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08/08/2005 |
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Target sample size:
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27 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-000219-24 |
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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: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Countries of recruitment
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Belgium
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Germany
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Italy
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Spain
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United Kingdom
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
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:
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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PATIENTS WITH CONGENITAL HEMOPHILIA A
MedDRA version: 6.1
Level: PT
Classification code 10016080
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Intervention(s)
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Trade Name: REFACTO*IV 1FL 1000UI+FL 4ML
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1000-
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Primary Outcome(s)
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Main Objective: Descrivere i patterns di anticorpi e degli epitopi associati in un sottogruppo di pazienti affetti da emofilia A che soddisfino i criteri di inclusione del protocollo, utilizzando la metodologia descritta in questo protocollo.
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Primary end point(s): Descrivere i patterns di anticorpi e degli epitopi associati in un sottogruppo di pazienti affetti da emofilia A che soddisfino i criteri di inclusione del protocollo, utilizzando la metodologia descritta in questo protocollo.
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Secondary Objective:
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Secondary ID(s)
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2004-000219-24-GB
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3082A-101342 EudraCT 2004-000219-24
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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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