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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-10-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Detailed Description

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Conditions

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Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Intervention Type DRUG

Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .

Interventions

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Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .

Intervention Type DRUG

Eligibility Criteria

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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