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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006965
Other study ID # PK HemoA-SP
Secondary ID STH-OCT-2016-01
Status Completed
Phase
First received
Last updated
Start date November 11, 2016
Est. completion date December 22, 2022

Study information

Verified date June 2023
Source Spanish Society of Thrombosis and Haemostasis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 22, 2022
Est. primary completion date December 22, 2022
Accepts healthy volunteers No
Gender Male
Age group 1 Year to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
octocog alfa
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
rurioctocog alfa pegol
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software

Locations

Country Name City State
Spain Complexo Hospitalario Universitario A Coruña A Coruna A Coruña
Spain Hospital Universitario Cruces Barakaldo Vizcaya
Spain Hospital Vall D'Hebron Barcelona
Spain Hospital Universitario Virgen de la Arrixaca El Palmar Murcia
Spain Hospital Sant Joan de Deu Esplugues de Llobregat Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Hospital Materno-infantil de Málaga Malaga
Spain Hospital Regional Universitario de Málaga Malaga
Spain Hospital Universitario Central de Asturias Oviedo Asturias
Spain Hospital Universitario Son Espases Palma Islas Baleares
Spain Hospital Virgen del Camino Pamplona Navarra
Spain Hospital Universitario Virgen del Rocío Sevilla
Spain Hospital Universitari i Politècnic La Fe Valencia
Spain Hospital Xeral de Vigo Vigo Pontevedra

Sponsors (3)

Lead Sponsor Collaborator
Spanish Society of Thrombosis and Haemostasis Instituto de Investigación Hospital Universitario La Paz, Takeda

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pharmacokinetic profile: FVIII half-life measured with MyPKFiT Change from Baseline to 12 months 3-4 hours postdose +/- 30 minutes
Primary Pharmacokinetic profile: FVIII half-life measured with MyPKFiT Change from Baseline to 12 months 24-32 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: FVIII half-life measured with MyPKFiT Change from Baseline to 12 months 48 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: FVIII half-life measured with MyPKFiT Change from Baseline to 12 months 72 hours postdose
Primary Pharmacokinetic profile: Clearance measured with MyPKFiT Change from Baseline to 12 months 3-4 hours postdose +/- 30 minutes
Primary Pharmacokinetic profile: Clearance measured with MyPKFiT Change from Baseline to 12 months 24-32 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: Clearance measured with MyPKFiT Change from Baseline to 12 months 48 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: Clearance measured with MyPKFiT Change from Baseline to 12 months 72 hours postdose
Primary Pharmacokinetic profile: Volume in steady state measured with MyPKFiT Change from Baseline to 12 months 3-4 hours postdose +/- 30 minutes
Primary Pharmacokinetic profile: Volume in steady state measured with MyPKFiT Change from Baseline to 12 months 24-32 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: Volume in steady state measured with MyPKFiT Change from Baseline to 12 months 48 hours postdose +/- 60 minutes
Primary Pharmacokinetic profile: Volume in steady state measured with MyPKFiT Change from Baseline to 12 months 72 hours postdose
Secondary Hemorrhagic risk of physical activity Measured with Broderick scale baseline
Secondary Hemorrhagic risk of physical activity Measured with Broderick scale month 12
Secondary Joint condition Hemophilia Joint Health Score baseline
Secondary Joint condition Hemophilia Joint Health Score month 12
Secondary Number of total bleeding episodes in a year Measured by annual bleeding record baseline
Secondary Number of total bleeding episodes in a year Measured by annual bleeding record month 12
Secondary Annual Joint Bleeding Record Hemophilia Joint Health Score baseline
Secondary Annual Joint Bleeding Record Hemophilia Joint Health Score month 12
Secondary Self-adherence to treatment evaluation Measured by VERITAS- PRO scale month 12
Secondary Adverse Events Collect and identify adverse events baseline
Secondary Adverse Events Collect and identify adverse events month 12
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