Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    WAPPS
Previous Study | Return to List | Next Study

Web Accessible Population Pharmacokinetics Service - Hemophilia: Sources of Variability (WAPPS-Hemo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03533504
Recruitment Status : Enrolling by invitation
First Posted : May 23, 2018
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
McMaster University

Brief Summary:
Using anonymized patient data collected as part of the WAPPS-Hemo project to explore the sources of variability in individual pharmacokinetics (PK); use the sources of variability to improve the performance of the WAPPS-Hemo models through the addition of the predictors of PK variability as covariates.

Condition or disease Intervention/treatment
Hemophilia A Hemophilia B Other: Variability in individual PK

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Exploring Sources of Variability in Individual Pharmacokinetics of Factor VIII and IX Concentrates in Hemophilia in the Web Accessible Population Pharmacokinetics Service - Hemophilia (WAPPS-Hemo) Database
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Group/Cohort Intervention/treatment
Variability in individual PK
Patients with hemophilia A or B, of any severity, who are registered on the web-accessible population pharmacokinetics- hemophilia (WAPPS-Hemo) database, and for whom infusion and/or PK data is available.
Other: Variability in individual PK
Multivariate hierarchical analysis will be performed on various factors (age, sex, weight, height, dose and type of factor administered (as total and IU/kg), blood group, baseline factor level, positive history of inhibitors, hematocrit, hemoglobin, and serum creatinine, laboratory methods used to measure factor VIII and factor IX) to explore sources of variability in patient outcome.




Primary Outcome Measures :
  1. Sources of variability in individual pharmacokinetics for factor VII and IX concentrates [ Time Frame: 2 years ]
    Multivariate hierarchical analysis will be performed on various factors (age, sex, weight, height, dose and type of factor administered (as total and IU/kg), blood group, baseline factor level, positive history of inhibitors, hematocrit, hemoglobin, and serum creatinine, laboratory methods used to measure factor VIII and factor IX) to explore sources of variability in patient outcome. Significant predictors will be used as covariates to improve the performance of WAPPS-Hemo models.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participates are individuals with hemophilia A or B, any severity, who have agreed to input of their data in the WAPPS-Hemo database, and who have sufficient infusion/PK data.
Criteria

Inclusion Criteria:

  • individuals with hemophilia A or B
  • infusion/PK data is available on the WAPPS-Hemo database
  • given informed consent to data input on the WAPPS-Hemo database

Exclusion Criteria:

- individuals currently undergoing immune tolerance induction


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533504


Locations
Layout table for location information
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S4B2
Sponsors and Collaborators
McMaster University
Investigators
Layout table for investigator information
Principal Investigator: Alfonso Iorio McMaster University
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03533504    
Other Study ID Numbers: 14-601-D
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
pharmacokinetics
hemophilia
factor VII
factor IX
population pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked