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

Spanish Society of Thrombosis and Haemostasis50 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hemophilia A Hemophilia Factor VIII Deficiency

Interventions

octocog alfaDRUG

Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

rurioctocog alfa pegolDRUG

Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

Eligibility

Sex: MALEMin age: 1 YearMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male patients. * Age between 1 and 65 years old. * Patients diagnosed with Hemophilia A who are on prophylactic treatment with Advate® or Adynovi® or adjusted with myPKFIT. * Patients older than 18 who have signed the informed consent form. * In the case of mature minors, in addition to the consent signed by the legal guardian, an assent of the minor must be obtain. * In the case of patients legally incapable for giving their consent, their primary caregiver will consent as the patient's legal guardian. Exclusion Criteria: * Withdrawal of informed consent. * Patients with any medical or psychological condition that according to the researcher's criteria prevents them from following the usual clinical practice procedures. * Patients with concomitant diagnosis of other haemostasis disorders. * Patients being treated for induction of immunologic tolerance at the time of inclusion.

Locations (14)

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Son Espases

Palma, Balearic Islands, Spain

Hospital Sant Joan de Deu

Esplugues de Llobregat, Barcelona, Spain