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

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

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.

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.