check_circleStudy Completed

Haemophilia A

Bayer Identifier:

15453

ClinicalTrials.gov Identifier:

NCT01436825

EudraCT Number:

Not Available

EU CT Number:

Not Available
Validation study of a cOmputer Pharmacokinetic Tool to assIst in the follow up care of haeMophilia A patients

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

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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
  • - Patients with haemophilia B

Trial summary

Enrollment Goal
69
Trial Dates
October 2011 - July 2015
Phase
N/A
Could I Receive a placebo
No
Products
Kogenate FS (Recombinant Factor VIII, BAY14-2222)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, France
Completed
Many Locations, Italy

Primary Outcome

  • The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool
    date_rangeTime Frame:
    after 1 month
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    Safety Issue:
    No
  • The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
    date_rangeTime Frame:
    after 1 month
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    Safety Issue:
    No
  • The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool
    date_rangeTime Frame:
    after 1 month
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    Safety Issue:
    No

Secondary Outcome

  • The dosage of factor VIII calculated by OPTIMS calculator
    date_rangeTime Frame:
    within 48 hours after enrollment
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    Safety Issue:
    No
  • The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire
    date_rangeTime Frame:
    within 48 hours after enrollment
    enhanced_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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