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Completed

NCT Number: NCT03006965

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

octocog alfa

Drug

Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

Other names: Advate®, recombinant intravenous factor VIII

rurioctocog alfa pegol

Drug

Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

Other names: recombinant intravenous factor VIII

Primary outcomes

  1. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT

    Time frame: 3-4 hours postdose +/- 30 minutes

    Change from Baseline to 12 months

  2. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT

    Time frame: 24-32 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  3. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT

    Time frame: 48 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  4. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT

    Time frame: 72 hours postdose

    Change from Baseline to 12 months

  5. Pharmacokinetic profile: Clearance measured with MyPKFiT

    Time frame: 3-4 hours postdose +/- 30 minutes

    Change from Baseline to 12 months

  6. Pharmacokinetic profile: Clearance measured with MyPKFiT

    Time frame: 24-32 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  7. Pharmacokinetic profile: Clearance measured with MyPKFiT

    Time frame: 48 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  8. Pharmacokinetic profile: Clearance measured with MyPKFiT

    Time frame: 72 hours postdose

    Change from Baseline to 12 months

  9. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT

    Time frame: 3-4 hours postdose +/- 30 minutes

    Change from Baseline to 12 months

  10. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT

    Time frame: 24-32 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  11. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT

    Time frame: 48 hours postdose +/- 60 minutes

    Change from Baseline to 12 months

  12. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT

    Time frame: 72 hours postdose

    Change from Baseline to 12 months

Secondary outcomes

  1. Hemorrhagic risk of physical activity

    Time frame: baseline

    Measured with Broderick scale

  2. Hemorrhagic risk of physical activity

    Time frame: month 12

    Measured with Broderick scale

  3. Joint condition

    Time frame: baseline

    Hemophilia Joint Health Score

  4. Joint condition

    Time frame: month 12

    Hemophilia Joint Health Score

  5. Number of total bleeding episodes in a year

    Time frame: baseline

    Measured by annual bleeding record

  6. Number of total bleeding episodes in a year

    Time frame: month 12

    Measured by annual bleeding record

  7. Annual Joint Bleeding Record

    Time frame: baseline

    Hemophilia Joint Health Score

  8. Annual Joint Bleeding Record

    Time frame: month 12

    Hemophilia Joint Health Score

  9. Self-adherence to treatment evaluation

    Time frame: month 12

    Measured by VERITAS- PRO scale

  10. Adverse Events

    Time frame: baseline

    Collect and identify adverse events

  11. Adverse Events

    Time frame: month 12

    Collect and identify adverse events

Sponsors and collaborators

Lead sponsor

Spanish Society of Thrombosis and Haemostasis

Other

Collaborators

  • Instituto de Investigación Hospital Universitario La Paz
  • Takeda

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 30, 2016
Registry last updated
Jun 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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