Status:
COMPLETED
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
Lead Sponsor:
Bayer
Conditions:
Haemophilia A
Eligibility:
All Genders
Brief Summary
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A ...
Eligibility Criteria
Inclusion
- Patient with severe haemophilia A defined as residual factor VIII activity \< 1%
- or Patient with moderate haemophilia A (residual factor VIII activity \>1% and \<5%) with severe clinical profile
- Patient treated in prevention with the same plasma or recombinant factor VIII for at least 6 months
- Patient whose inclusion visit is performed during a routine visit including a measurement of plasma residual factor VIII :c level
- In the medical file (retrospective data) the pharmacokinetic parameters are available and have been obtained from a PK analysis of factor VIII level performed with the same anti haemophilic factor than the one used on the inclusion day
Exclusion
- Patients with haemophilia B
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT01436825
Start Date
October 1 2011
End Date
July 1 2015
Last Update
August 10 2015
Active Locations (2)
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1
Many Locations, France
2
Many Locations, Italy