Trial Condition(s):
Haemophilia A
Validation study of a cOmputer Pharmacokinetic Tool to assIst in the follow up care of haeMophilia A patients (OPTIMS)
Bayer Identifier:
15453
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A validation study of the OPTIMS pharmacokinetic calculator for clinician use in prophylactic treatment of patients with haemophilia A.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS ToolTimeframe: after 1 month
- The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS ToolTimeframe: after 1 month
- The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS ToolTimeframe: after 1 month
Secondary Outcome
- The dosage of factor VIII calculated by OPTIMS calculatorTimeframe: within 48 hours after enrollment
- The practicality of the OPTIMS calculator by a physician's satisfaction questionnaireTimeframe: within 48 hours after enrollment
Additional Information
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