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

Completed

• Conditions: Haemophilia A
• Interventions: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

• Registration Number: NCT01436825
• Lead Sponsor: Bayer

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 with a severe clinical profile.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-19
• Study First Posted: 2011-09-20
• Study Start: 2011-10
• Primary Completion: 2014-06
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-07
• Last Update Posted: 2015-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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

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Exclusion Criteria

• Patients with haemophilia B

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Recombinant Factor VIII (Kogenate FS, BAY14-2222)	-

Primary Outcome Measures

Name	Time	Method
The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool	after 1 month
The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool	after 1 month
The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool	after 1 month

Secondary Outcome Measures

Name	Time	Method
The dosage of factor VIII calculated by OPTIMS calculator	within 48 hours after enrollment
The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire	within 48 hours after enrollment