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

Sponsor
Spanish Society of Thrombosis and Haemostasis (Other)
Overall Status
Recruiting
CT.gov ID
NCT03006965
Collaborator
Takeda (Industry), Instituto de Investigación Hospital Universitario La Paz (Other)
100
Enrollment
14
Locations
65.3
Anticipated Duration (Months)
7.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: octocog alfa
  • Drug: rurioctocog alfa pegol

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Other
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
Actual Study Start Date :
Nov 11, 2016
Anticipated Primary Completion Date :
Dec 22, 2021
Anticipated Study Completion Date :
Apr 22, 2022

Arms and Interventions

Arm Intervention/Treatment
Hemophilia A patients

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.

Drug: octocog alfa
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Other Names:
  • Advate®
  • recombinant intravenous factor VIII

    • Drug: rurioctocog alfa pegol
    Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
    Other Names:
  • recombinant intravenous factor VIII

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT [3-4 hours postdose +/- 30 minutes]

      Change from Baseline to 12 months

    2. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT [24-32 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    3. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT [48 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    4. Pharmacokinetic profile: FVIII half-life measured with MyPKFiT [72 hours postdose]

      Change from Baseline to 12 months

    5. Pharmacokinetic profile: Clearance measured with MyPKFiT [3-4 hours postdose +/- 30 minutes]

      Change from Baseline to 12 months

    6. Pharmacokinetic profile: Clearance measured with MyPKFiT [24-32 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    7. Pharmacokinetic profile: Clearance measured with MyPKFiT [48 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    8. Pharmacokinetic profile: Clearance measured with MyPKFiT [72 hours postdose]

      Change from Baseline to 12 months

    9. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT [3-4 hours postdose +/- 30 minutes]

      Change from Baseline to 12 months

    10. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT [24-32 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    11. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT [48 hours postdose +/- 60 minutes]

      Change from Baseline to 12 months

    12. Pharmacokinetic profile: Volume in steady state measured with MyPKFiT [72 hours postdose]

      Change from Baseline to 12 months

    Secondary Outcome Measures

    1. Hemorrhagic risk of physical activity [baseline]

      Measured with Broderick scale

    2. Hemorrhagic risk of physical activity [month 12]

      Measured with Broderick scale

    3. Joint condition [baseline]

      Hemophilia Joint Health Score

    4. Joint condition [month 12]

      Hemophilia Joint Health Score

    5. Number of total bleeding episodes in a year [baseline]

      Measured by annual bleeding record

    6. Number of total bleeding episodes in a year [month 12]

      Measured by annual bleeding record

    7. Annual Joint Bleeding Record [baseline]

      Hemophilia Joint Health Score

    8. Annual Joint Bleeding Record [month 12]

      Hemophilia Joint Health Score

    9. Self-adherence to treatment evaluation [month 12]

      Measured by VERITAS- PRO scale

    10. Adverse Events [baseline]

      Collect and identify adverse events

    11. Adverse Events [month 12]

      Collect and identify adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Complexo Hospitalario Universitario A Coruña A Coruna A Coruña Spain 15006
    2 Hospital Universitario Central de Asturias Oviedo Asturias Spain 33011
    3 Hospital Sant Joan de Deu Esplugues de Llobregat Barcelona Spain 08950
    4 Hospital Universitario Son Espases Palma Islas Baleares Spain 07120
    5 Hospital Universitario Virgen de la Arrixaca El Palmar Murcia Spain 30120
    6 Hospital Virgen del Camino Pamplona Navarra Spain 31008
    7 Hospital Xeral de Vigo Vigo Pontevedra Spain 36212
    8 Hospital Universitario Cruces Barakaldo Vizcaya Spain 48903
    9 Hospital Vall D'Hebron Barcelona Spain 08035
    10 Hospital Universitario La Paz Madrid Spain 28046
    11 Hospital Regional Universitario de Málaga Malaga Spain 29010
    12 Hospital Materno-infantil de Málaga Malaga Spain 29011
    13 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
    14 Hospital Universitari i Politècnic La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Spanish Society of Thrombosis and Haemostasis
    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spanish Society of Thrombosis and Haemostasis
    ClinicalTrials.gov Identifier:
    NCT03006965
    Other Study ID Numbers:
    • PK HemoA-SP
    • STH-OCT-2016-01
    First Posted:
    Dec 30, 2016
    Last Update Posted:
    Mar 17, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Spanish Society of Thrombosis and Haemostasis
    Hemophilia
    Hemophilia A
    Factor VIII
    Advate
    Antithrombotic factor
    Pharmacokinetic dosing
    Hemarthrosis
    myPKFiT
    Additional relevant MeSH terms:
    Hemophilia A
    Factor VIII
    BAX 855

    Study Results

    No Results Posted as of Mar 17, 2021