Web Accessible Population Pharmacokinetics Service - Hemophilia: Sources of Variability

NCT03533504 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2023-03-15

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Alfonso Iorio · McMaster University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-09
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533504 on ClinicalTrials.gov