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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-000720-16-IT
Date of registration: 19/03/2007
Prospective Registration: No
Primary sponsor: WYETH LEDERLE
Public title: 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
Scientific title: 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: 27/10/2005
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000720-16
Study type:  Interventional clinical trial of medicinal product
Study design:  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:  
Phase: 
Countries of recruitment
Belgium Finland Germany Hungary Italy Spain Sweden
Contacts
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Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
HAEMORRAGIES PREVENTION AND CONTROL IN COAGULATION FACTOR VIII - DEFICIT PATIENTS DUE TO HAEMOPHILIA A
Intervention(s)

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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Secondary Outcome(s)
Secondary ID(s)
3082B2-310 WW
2005-000720-16-HU
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
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