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

Haemophilia A Clinical Trial

— OPTIMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436825
• Other study ID #: 15453
• Secondary ID: KG110FR
• Status: Completed
• Phase: N/A
• First received: September 14, 2011
• Last updated: August 7, 2015
• Start date: October 2011
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France : noneItaly: Ministry of Health
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: July 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Haemophilia A
• Hemophilia A

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of the recovery rate calculated by the physician and the recovery rate calculated by an independent calculator With OPTIMS Tool		after 1 month	No
Primary	The difference of the elimination half-life calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool		after 1 month	No
Primary	The difference of the clearance calculated by the physician and the ones calculated by an independent calculator With OPTIMS Tool		after 1 month	No
Secondary	The dosage of factor VIII calculated by OPTIMS calculator		within 48 hours after enrollment	No
Secondary	The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire		within 48 hours after enrollment	No

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