Clinical trial

Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm

Name
PK HemoA-SP
Description
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
Trial arms
Trial start
2016-11-11
Estimated PCD
2022-12-22
Trial end
2022-12-22
Status
Completed
Treatment
octocog alfa
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Arms:
Hemophilia A patients
Other names:
Advate®, recombinant intravenous factor VIII
rurioctocog alfa pegol
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Arms:
Hemophilia A patients
Other names:
recombinant intravenous factor VIII
Size
50
Primary endpoint
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
3-4 hours postdose +/- 30 minutes
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
24-32 hours postdose +/- 60 minutes
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
48 hours postdose +/- 60 minutes
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
72 hours postdose
Pharmacokinetic profile: Clearance measured with MyPKFiT
3-4 hours postdose +/- 30 minutes
Pharmacokinetic profile: Clearance measured with MyPKFiT
24-32 hours postdose +/- 60 minutes
Pharmacokinetic profile: Clearance measured with MyPKFiT
48 hours postdose +/- 60 minutes
Pharmacokinetic profile: Clearance measured with MyPKFiT
72 hours postdose
Pharmacokinetic profile: Volume in steady state measured with MyPKFiT
3-4 hours postdose +/- 30 minutes
Pharmacokinetic profile: Volume in steady state measured with MyPKFiT
24-32 hours postdose +/- 60 minutes
Pharmacokinetic profile: Volume in steady state measured with MyPKFiT
48 hours postdose +/- 60 minutes
Pharmacokinetic profile: Volume in steady state measured with MyPKFiT
72 hours postdose
Eligibility criteria
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.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood samples collected in citrate plasma tubes to separate it and measure FVIII:chromogenic and FVIII:one stage'}, 'enrollmentInfo': {'count': 50, 'type': 'ACTUAL'}}
Updated at
2023-06-08

1 organization

2 products

2 indications

Indication
Hemophilia A
Indication
Hemophilia