Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
NCT ID: NCT00927667
Last Updated: 2013-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2009-06-30
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Arm 1
No Drug
Patients have received primary FVIII prophylaxis (started \< 2 years of age)
Arm 2
No Drug
Patients have received secondary FVIII prophylaxis (started 2 - \< 6 years of age)
Arm 3
No Drug
Patients have received secondary FVIII prophylaxis (started 6 - \< 12 years of age)
Arm 4
No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
Arm 5
No Drug
Patients have received on-demand therapy
Interventions
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No Drug
Patients have received primary FVIII prophylaxis (started \< 2 years of age)
No Drug
Patients have received secondary FVIII prophylaxis (started 2 - \< 6 years of age)
No Drug
Patients have received secondary FVIII prophylaxis (started 6 - \< 12 years of age)
No Drug
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
No Drug
Patients have received on-demand therapy
Eligibility Criteria
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Inclusion Criteria
* Severe hemophilia A ( \< 1 % FVIII:C)
* No history of Factor VIII inhibitory antibody
* For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
* Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
* Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
* For the on-demand subjects \> 12 bleeds/year in the last 5 years.
* Written informed consent by subject and parent/legal representative, if \< 18 years
Exclusion Criteria
* HIV seropositive subjects
* Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
* HCV seropositive individuals who underwent interferon therapy during the last 12 months
* Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
* Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period
* Joint replacement
* For the on-demand treatment group, any period greater than 8 consecutive months having received \>/= 50 IU per kg per week Factor VIII for the prevention of bleeding
12 Years
35 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Healthcare AG
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Heidelberg, Baden-Wurttemberg, Germany
Bonn, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Magdeburg, Saxony-Anhalt, Germany
Athens, , Greece
Milan, , Italy
Padua, , Italy
Parma, , Italy
Roma, , Italy
A Coruña, A Coruña, Spain
Valencia, Valencia, Spain
Malmo, , Sweden
Stockholm, , Sweden
Canterbury, Kent, United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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2009-010147-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12948
Identifier Type: -
Identifier Source: org_study_id
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