Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Factor VIII Deficiency
- Hemophilia
- Hemophilia A
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Other
Participation Requirements
- Age
- Between 1 years and 65 years
- Gender
- Only males
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 meas...
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.
Tracking Information
- NCT #
- NCT03006965
- Collaborators
- Takeda
- Instituto de Investigación Hospital Universitario La Paz
- Investigators
- Principal Investigator: M Teresa Álvarez Román, MD,PhD Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid