Brief Title
Russian Kogenate Pediatric Study
Official Title
A Prospective Study to Evaluate the Effect of rFVIII-FS in Different Prophylactic Regimens on Bleeding Events Frequency and Development of Arthropathy in Previously Treated and Minimally Treated Hemophilia A Pediatric Population.
Brief Summary
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period
Secondary Outcome
Number of Bleeds Per Participant During the 9-month Treatment Period
Condition
Hemophilia A
Intervention
rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week
Study Arms / Comparison Groups
rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
Description: rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
32
Start Date
June 2007
Completion Date
September 2009
Primary Completion Date
September 2009
Eligibility Criteria
Inclusion Criteria: - Male - Severe hemophilia A or moderate hemophilia A - 1-12 years of age - Requiring treatment with FVIII Exclusion Criteria: - Current or prior inhibitor or familial antecedents of inhibitor - Surgery required during the study (9 months) - Positive for HIV
Gender
Male
Ages
1 Year - 12 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT00632814
Organization ID
12684
Secondary IDs
2014-005253-39
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
June 2015