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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. |
Register:
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EUCTR |
Last refreshed on:
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19 March 2012 |
Main ID: |
EUCTR2005-000720-16-IT |
Date of registration:
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19/03/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Randomized Two-way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII BDDrFVIII, ReFacto AF With a Full-Length Recombinant Factor VIII Preparation FLrFVIII, Advate , Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A
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Scientific title:
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A Randomized Two-way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII BDDrFVIII, ReFacto AF With a Full-Length Recombinant Factor VIII Preparation FLrFVIII, Advate , Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A |
Date of first enrolment:
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27/10/2005 |
Target sample size:
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100 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000720-16 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: yes
Open: yes
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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Finland
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Germany
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Hungary
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Italy
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Spain
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Sweden
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Contacts
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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: no Male: yes
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Health Condition(s) or Problem(s) studied
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HAEMORRAGIES PREVENTION AND CONTROL IN COAGULATION FACTOR VIII - DEFICIT PATIENTS DUE TO HAEMOPHILIA A
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Intervention(s)
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Product Name: ReFacto AF Recombinant B-domain deleted, monoclonal antibody, albumin free Factor VIII BDDrFVIII Product Code: ReFacto AF Pharmaceutical Form: Powder and solvent for solution for infusion CAS Number: 284036-24-4 Current Sponsor code: ReFacto AF Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 30-
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Primary Outcome(s)
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Primary end point(s):
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Main Objective:
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Secondary Objective:
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Secondary ID(s)
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3082B2-310 WW
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2005-000720-16-HU
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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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