Trial Condition(s):

Hemophilia A

Prophylaxis versus on demand treatment for children with Hemophilia A

Bayer Identifier:

16287

ClinicalTrials.gov Identifier:

NCT01810666

EudraCT Number:

2014-001362-10

Study Completed

Trial Purpose

Comparison of the effect of three times a week prophylaxis on all bleeds with on-demand treatment for children with severe Hemophilia A.

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

Trial Summary

Enrollment Goal
30
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Peking Union Medical College Hospital

Beijing, China, 100730

Status
Completed
 
Locations

Institute of Hematology & Blood Diseases Hospital Chinese Ac

Tianjin, China

Status
Completed
 
Locations

Beijing Children's Hospital

Beijing, China

Status
Completed
 
Locations

Union hospital of Tongji Medical College,Huazhong university

Wuhan, China, 430022

Status
Completed
 
Locations

Nanfang Hospital.

Guangzhou, China, 510515

Status
Completed
 

Trial Design