Status:
COMPLETED
Prophylaxis Versus on Demand Treatment for Children With Hemophilia A
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
2-16 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01810666
Start Date
March 1 2013
End Date
January 1 2014
Last Update
May 19 2015
Active Locations (5)
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1
Guangzhou, Guangdong, China, 510515
2
Wuhan, Hubei, China, 430022
3
Beijing, China, 100730
4
Beijing, China