Status:
COMPLETED
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
Lead Sponsor:
Bio Products Laboratory
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The main objective of the study is to compare the pharmacokinetics of Optivate® with the subject's current FVIII concentrate when given as a bolus dose of 50IU/kg. The secondary objective is to compar...
Eligibility Criteria
Inclusion
- Previously treated subjects with severe Haemophilia A (\<2% basal FVIII activity) without inhibitor to Factor VIII, at least 12 years of age, currently receiving FVIII concentrate and with more than 20 exposure days.
Exclusion
- \-
Key Trial Info
Start Date :
October 1 2001
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02246881
Start Date
October 1 2001
Last Update
February 15 2018
Active Locations (8)
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1
Klinika Haematologii, Akademia Medyczna w Gdansku, ul.
Debinki 7, 80-211 Gdansk, Poland
2
Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
Dr K Jaczewskiego 8, 20-090, Lublin, Poland
3
Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
Pabianicka 62, 93-513 Lodz, Poland
4
Haemophilia Centre, Addenbrooke's Hospital
Hills Road, Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ