Web-based Application for the Population Pharmacokinetic Service - Phase 1
NCT02061072 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400
Last updated 2021-03-16
Summary
The aims of this trials are:
1. to collect published and unpublished individual classic pharmacokinetic data (individual patient data from independent investigators and pharmaceutical companies)
2. to make available population pharmacokinetic models for the concentrates derived from the data collected
3. to develop a web based application intended to use the above models to calculate pharmacokinetic parameters for individual patients, and
4. to test the system functionality via simulation of the use of the prototype by use of faked test data.
Conditions
- Hemophilia A
- Hemophilia B
Interventions
- OTHER
-
Population pharmacokinetic estimation
Pre-existing individual PK data will be used to derive population PK models. Sparse concentration time data, acquired via a website, will be used to estimate individual pharmacokinetic parameters
Sponsors & Collaborators
-
Canadian Hemophilia Society
collaborator OTHER - lead OTHER
Principal Investigators
-
Alfonso Iorio, MD,PhD · McMaster University
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-31
- Primary Completion
- 2019-06-30
- Completion
- 2019-06-30
Countries
- Canada
Study Locations
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