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:

NCT01436825

EudraCT Number:

Not Available

Study Completed

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
69
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 

Trial Design