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

Bayer

Status: Completed

Conditions: Haemophilia A

Treatments: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study type: Observational

Funder types: Industry

Identifiers

NCT01436825

KG110FR (Other Identifier)

15453

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

69 participants in 1 patient group

Group 1

Treatment:

Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)