A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 69
- Primary Endpoint
- The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Intervention: Recombinant Factor VIII (Kogenate FS, BAY14-2222) (Drug)
Outcomes
Primary Outcomes
The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
Time Frame: 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
Time Frame: after 1 month
The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
Time Frame: after 1 month
Secondary Outcomes
- 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)