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

August 7, 2015 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Many Locations, France
  • Italy
      • Many Locations, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
after 1 month
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
after 1 month
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
after 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
The dosage of factor VIII calculated by OPTIMS calculator
Time Frame: within 48 hours after enrollment
within 48 hours after enrollment
The practicality of the OPTIMS calculator by a physician's satisfaction questionnaire
Time Frame: within 48 hours after enrollment
within 48 hours after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 19, 2011

First Posted (ESTIMATE)

September 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15453
  • KG110FR (OTHER: Company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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