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

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01436825
First received: September 14, 2011
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  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


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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Hemophilia
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as 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 [ Time Frame: after 1 month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The dosage of factor VIII calculated by OPTIMS calculator [ Time Frame: within 48 hours after enrollment ] [ Designated as safety issue: No ]
  • The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire [ Time Frame: within 48 hours after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436825

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
France
Recruiting
Many Locations, France
Italy
Not yet recruiting
Many Locations, Italy
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01436825     History of Changes
Other Study ID Numbers: 15453, KG110FR
Study First Received: September 14, 2011
Last Updated: April 2, 2013
Health Authority: France : none
Italy: Ministry of Health

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013