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Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®

Hemophilia A Clinical Trial

Official title:
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm

Clinical Trial Summary

The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®

Clinical Trial Description

This pharmacokinetic profile will be obtained in only in patient using Advate® (INN-octocog alfa) or Adynovi® (INN- rurioctocog alfa pegol), both recombinant intravenous FVIII products, with myPKFiT®. This patients will be followed during the period of 12 months, and the pharmacokinetic will be measured collecting at least 2 blood samples, in which the presence of factor VIII will be determined by the usual clinical methods: chromogenic method or coagulative method. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03006965
Study type Observational
Source Spanish Society of Thrombosis and Haemostasis
Contact
Status Completed
Phase
Start date November 11, 2016
Completion date December 22, 2022
View Details
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