Brief Title
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
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
Brief Summary
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
Detailed 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 Type
Observational
Primary Outcome
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
Secondary Outcome
Hemorrhagic risk of physical activity
Condition
Hemophilia A
Intervention
octocog alfa
Study Arms / Comparison Groups
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
November 11, 2016
Completion Date
April 22, 2022
Primary Completion Date
December 22, 2021
Eligibility Criteria
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.
Gender
Male
Ages
1 Year - 65 Years
Accepts Healthy Volunteers
No
Contacts
M Teresa Álvarez Román, MD,PhD, +34 913582211, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT03006965
Organization ID
PK HemoA-SP
Secondary IDs
STH-OCT-2016-01
Responsible Party
Sponsor
Study Sponsor
Spanish Society of Thrombosis and Haemostasis
Collaborators
Takeda
Study Sponsor
M Teresa Álvarez Román, MD,PhD, Principal Investigator, Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid
Verification Date
March 2021