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

Spanish Society of Thrombosis and Haemostasis

Status: Completed

Conditions: Factor VIII Deficiency; Hemophilia A; Hemophilia

Treatments: Drug: octocog alfa; Drug: rurioctocog alfa pegol

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03006965

STH-OCT-2016-01 (Other Identifier)

PK HemoA-SP

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 1 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Hemophilia A patients

Description:

Group of patients in prophylactic treatment with Advate® (octocog alfa) or Adynovi® (rurioctocog alfa pegol), or patients using already myPKFit®. Patients will be given a dose of octocog alfa or rurioctocog alfa pegol according to usual clinical practice, and two blood samples will be taken in case of octocog alfa: one sample will be extracted 3-4h postdose (+/- 30 minutes), and the second sample will be extracted 24-32h postdose (+/- 60 minutes). In case of rurioctocog alfa pegol, the first sample is taken in the same conditions than octocog alfa, and the second sample will be extracted 48h postdose (+/- 120 minutes), and other sample post 72h(+/- 120 minutes) optional.

Treatment:

Drug: rurioctocog alfa pegol

Drug: octocog alfa