Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT® (NCT03006965) | Clinical Trial Compass
CompletedNot Applicable
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
Spain50 participantsStarted 2016-11-11
Plain-language summary
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
Who can participate
Age range1 Year – 65 Years
SexMALE
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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.
What they're measuring
1
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
Timeframe: 3-4 hours postdose +/- 30 minutes
2
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
Timeframe: 24-32 hours postdose +/- 60 minutes
3
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
Timeframe: 48 hours postdose +/- 60 minutes
4
Pharmacokinetic profile: FVIII half-life measured with MyPKFiT
Timeframe: 72 hours postdose
5
Pharmacokinetic profile: Clearance measured with MyPKFiT
Timeframe: 3-4 hours postdose +/- 30 minutes
6
Pharmacokinetic profile: Clearance measured with MyPKFiT
Timeframe: 24-32 hours postdose +/- 60 minutes
7
Pharmacokinetic profile: Clearance measured with MyPKFiT
Timeframe: 48 hours postdose +/- 60 minutes
8
Pharmacokinetic profile: Clearance measured with MyPKFiT
Trial details
NCT IDNCT03006965
SponsorSpanish Society of Thrombosis and Haemostasis