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Register:	ClinicalTrials.gov
Last refreshed on:	20 June 2023
Main ID:	NCT03006965
Date of registration:	22/12/2016
Prospective Registration:	No
Primary sponsor:	Spanish Society of Thrombosis and Haemostasis
Public title:	Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
Scientific 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
Date of first enrolment:	November 11, 2016
Target sample size:	50
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03006965
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Spain

Contacts

Name:	M Teresa Álvarez Román, MD,PhD
Address:
Telephone:
Email:
Affiliation:	Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid

Key inclusion & exclusion 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.

Age minimum: 1 Year
Age maximum: 65 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Factor VIII Deficiency

Hemophilia

Hemophilia A

Intervention(s)

Drug: octocog alfa

Drug: rurioctocog alfa pegol

Primary Outcome(s)

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

Pharmacokinetic profile: Clearance measured with MyPKFiT [Time Frame: 72 hours postdose]

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

Pharmacokinetic profile: FVIII half-life measured with MyPKFiT [Time Frame: 72 hours postdose]

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

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

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

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

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

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

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

Pharmacokinetic profile: Volume in steady state measured with MyPKFiT [Time Frame: 72 hours postdose]

Secondary Outcome(s)

Joint condition [Time Frame: baseline]

Number of total bleeding episodes in a year [Time Frame: month 12]

Hemorrhagic risk of physical activity [Time Frame: baseline]

Self-adherence to treatment evaluation [Time Frame: month 12]

Annual Joint Bleeding Record [Time Frame: month 12]

Joint condition [Time Frame: month 12]

Hemorrhagic risk of physical activity [Time Frame: month 12]

Adverse Events [Time Frame: baseline]

Adverse Events [Time Frame: month 12]

Annual Joint Bleeding Record [Time Frame: baseline]

Number of total bleeding episodes in a year [Time Frame: baseline]

Secondary ID(s)

STH-OCT-2016-01

PK HemoA-SP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Takeda

Instituto de Investigación Hospital Universitario La Paz

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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