octocog alfa
DrugPharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Other names: Advate®, recombinant intravenous factor VIII
NCT Number: NCT03006965
The purpose of this study is to describe the pharmacokinetic profile of patients with hemophilia A in prophylaxis in Spain using myPKFit®
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Notify Me1 year–65 year
Male
Observational
Complexo Hospitalario Universitario A Coruña, A Coruña, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Other names: Advate®, recombinant intravenous factor VIII
Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
Other names: recombinant intravenous factor VIII
Time frame: 3-4 hours postdose +/- 30 minutes
Change from Baseline to 12 months
Time frame: 24-32 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 48 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 72 hours postdose
Change from Baseline to 12 months
Time frame: 3-4 hours postdose +/- 30 minutes
Change from Baseline to 12 months
Time frame: 24-32 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 48 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 72 hours postdose
Change from Baseline to 12 months
Time frame: 3-4 hours postdose +/- 30 minutes
Change from Baseline to 12 months
Time frame: 24-32 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 48 hours postdose +/- 60 minutes
Change from Baseline to 12 months
Time frame: 72 hours postdose
Change from Baseline to 12 months
Time frame: baseline
Measured with Broderick scale
Time frame: month 12
Measured with Broderick scale
Time frame: baseline
Hemophilia Joint Health Score
Time frame: month 12
Hemophilia Joint Health Score
Time frame: baseline
Measured by annual bleeding record
Time frame: month 12
Measured by annual bleeding record
Time frame: baseline
Hemophilia Joint Health Score
Time frame: month 12
Hemophilia Joint Health Score
Time frame: month 12
Measured by VERITAS- PRO scale
Time frame: baseline
Collect and identify adverse events
Time frame: month 12
Collect and identify adverse events
Spanish Society of Thrombosis and Haemostasis
Other
Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using an Online Medical Application Based on a Published Population Model and a Bayesian Algorithm
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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