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

Tracking Information

First Received Date ^ICMJE

September 14, 2011

Last Updated Date

April 2, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01436825 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Validation Study of the OPTIMS Pharmacokinetic Calculator for Clinician Use in Prophylactic Treatment of Patients With Haemophilia A.

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition ^ICMJE

Haemophilia A

Intervention ^ICMJE

Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .

Study Group/Cohort (s)

Group 1

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Location Countries ^ICMJE

France, Italy

Administrative Information

NCT Number ^ICMJE

NCT01436825

Other Study ID Numbers ^ICMJE

15453, KG110FR

Has Data Monitoring Committee

Responsible Party

Medical Director, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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