Brief Title
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
Official Title
A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
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
Study Type
Observational
Primary Outcome
The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
Secondary Outcome
The dosage of factor VIII calculated by OPTIMS calculator
Condition
Haemophilia A
Intervention
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Study Arms / Comparison Groups
Group 1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
69
Start Date
October 2011
Completion Date
July 2015
Primary Completion Date
June 2014
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bayer Study Director, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01436825
Organization ID
15453
Secondary IDs
KG110FR
Responsible Party
Sponsor
Study Sponsor
Bayer
Study Sponsor
Bayer Study Director, Study Director, Bayer
Verification Date
August 2015