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Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Sponsor: Children's Hospital of Fudan University
Summary
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis
Official title: Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
OBSERVATIONAL
Enrollment
60
Start Date
2023-01-01
Completion Date
2026-12-31
Last Updated
2025-05-29
Healthy Volunteers
No
Conditions
Locations (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China