Brief Title
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Official Title
Routine Prophylaxis Treatment Versus On-demand Treatment for Children With Severe Hemophilia A: Comparison of All Bleeding Events in Chinese Hemophilia Patients
Brief Summary
Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Difference of Annualized Number of All Bleeds Between On-demand and Prophylaxis Period
Secondary Outcome
Difference of Annualized Number of Joint Bleeds Between On-demand and Prophylaxis Period
Condition
Hemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Recombinant Factor VIII
Description:
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
Biological
Estimated Enrollment
30
Start Date
March 2013
Completion Date
January 2014
Primary Completion Date
January 2014
Eligibility Criteria
Inclusion Criteria: - Male, aged 2-16yrs - Severe hemophilia A (<1% FVIII:C [Blood Clotting Factor VIII:C] ) - Minimum of at least 50 documented ED (exposure day) prior to enrolment - No measurable inhibitor activity at baseline and history of FVIII inhibitor antibody formation - Parents or legal guardians document, sign, and date informed consent Exclusion Criteria: - Another bleeding disease that is different from hemophilia A - Known hypersensitivity to the active substance, mouse or hamster protein - Thrombocytopenia (platelet count <100 000/mm3) based on previous medical records
Gender
Male
Ages
2 Years - 16 Years
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01810666
Organization ID
16287
Secondary IDs
2014-001362-10
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
April 2015