Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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 with a severe clinical profile.

The study takes place during a single visit, at the time of patient enrollment in the study

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

Inclusion Criteria:

• 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 Criteria:

• Patients with haemophilia B