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

NCT01436825 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2015-08-10

No results posted yet for this study

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

Conditions

  • Haemophilia A

Interventions

DRUG

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-06-30
Completion
2015-07-31

Countries

  • France
  • Italy

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01436825 on ClinicalTrials.gov