Status:
COMPLETED
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
12-35 years
Phase:
PHASE4
Brief Summary
The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study m...
Eligibility Criteria
Inclusion
- Males aged 12 - 35 years
- 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
- Individuals with other coagulopathies (e.g., von Willebrand disease)
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00927667
Start Date
June 1 2009
End Date
December 1 2010
Last Update
February 20 2013
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Heidelberg, Baden-Wurttemberg, Germany, 69123
2
Bonn, North Rhine-Westphalia, Germany, 53105
3
Münster, North Rhine-Westphalia, Germany, 48143
4
Magdeburg, Saxony-Anhalt, Germany, 39112