NCT03006965

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Spanish Society of Thrombosis and Haemostasis · Academic / Other
• Sex: Male
• Age: 1 Year – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A
• Hemophilia
• Factor VIII Deficiency

Interventions

Type	Name	Description
DRUG	octocog alfa	Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
DRUG	rurioctocog alfa pegol	Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

Timeline

• Start date: 2016-11-11
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2016-12-30
• Last updated: 2023-06-08

Locations

14 sites across 1 country: Spain