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Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients (OPTIMS)

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ClinicalTrials.gov Identifier: NCT01436825
Recruitment Status : Completed
First Posted : September 20, 2011
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment
Haemophilia A Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Study Design

Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.
Study Start Date : October 2011
Primary Completion Date : June 2014
Study Completion Date : July 2015


Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 Outcome Measures :
  1. The dosage of factor VIII calculated by OPTIMS calculator [ Time Frame: within 48 hours after enrollment ]
  2. The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire [ Time Frame: within 48 hours after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • 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 clinical signs of frequent, severe bleeding episodes
  • Patient treated prophylatically with the same plasma or recombinant factor VIII for at least 6 months
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01436825


Locations
France
Many Locations, France
Italy
Many Locations, Italy
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01436825     History of Changes
Other Study ID Numbers: 15453
KG110FR ( Other Identifier: Company internal )
First Posted: September 20, 2011    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: August 2015

Keywords provided by Bayer:
Haemophilia A
Factor VIII
Pharmacokinetic
Computer Tool validation

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants