Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
NCT ID: NCT03006965
Last Updated: 2023-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
50 participants
OBSERVATIONAL
2016-11-11
2022-12-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk Models to Optimise Prophylaxis Schedules in Children With Haemophilia
NCT02585635
Assess the Efficacy and Safety of Personalized Prophylaxis Human-cl rhFVIII in Patients With Severe Haemophilia A
NCT02256917
Optimizing the Use of Prophylaxis in Patients With Severe Haemophilia A
NCT03915080
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
NCT01662531
Association of Prophylactic Treatment With Treatment Burden and Psychosocial Variables in Patients With Hemophilia
NCT07099313
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
OTHER
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
1 Year
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
INDUSTRY
Instituto de Investigación Hospital Universitario La Paz
OTHER
Spanish Society of Thrombosis and Haemostasis
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
M Teresa Álvarez Román, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario La Paz, IdiPAZ, Universidad Autónoma de Madrid
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Complexo Hospitalario Universitario A Coruña
A Coruña, A Coruña, Spain
Hospital Universitario Son Espases
Palma, Balearic Islands, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Virgen del Camino
Pamplona, Navarre, Spain
Hospital Xeral de Vigo
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
Hospital Materno-infantil de Málaga
Málaga, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STH-OCT-2016-01
Identifier Type: OTHER
Identifier Source: secondary_id
PK HemoA-SP
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.