Status:
COMPLETED
A Study to Investigate the Safety and Efficacy of Optivate® in Children Under 6 Years of Age With Haemophilia A.
Lead Sponsor:
Bio Products Laboratory
Conditions:
Haemophilia A
Eligibility:
All Genders
Up to 6 years
Phase:
PHASE3
Brief Summary
The main objectives of this study are: * to assess Optivate® consumption (IU/kg consumed per month for prophylactic and on-demand therapy and dose at each bleed). * to assess clinical outcome when tr...
Eligibility Criteria
Inclusion
- Children under the age of 6 years with a diagnosis of severe Haemophilia A. Subjects who required FVIII therapy and did not demonstrate inhibitors to FVIII.
- Children with history of inhibitors to FVIII or clinically significant renal or liver disease were not eligible to participate in the study.
Exclusion
- \-
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02246894
Start Date
November 1 2003
Last Update
February 15 2018
Active Locations (5)
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1
Children's Haematology and Oncology Clinic, Ul.
W. Chodzki Str., Lublin Voivodeship, Poland, 20-093
2
Academic Children's Hospital, Children's Haematology and Oncology, Clinic 265 Wielicka str.
Krakow, Poland, 30-663
3
Specialist Centre for Medical Care of Mother and Children, Internal Ward 1, 7/8 Dr B. Krysiewicza str.
Poznan, Poland, 61-825
4
Department of Paediatrics, Haematology and Oncology, Medical University of Warsaw, 24 Marszalkowska str.
Warsaw, Poland, 00-576