Skip to main content
OpenTrials
Completed

NCT Number: NCT01436825

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Haemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: OPTIMS

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Sep 20, 2011
Registry last updated
Aug 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.