Trials / Recruiting
RecruitingNCT06993636
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Academic / Other
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
- Kawasaki Disease
- Coronary Artery Aneurysm
- Rivaroxaban
- Anticoagulant Drugs
- Pharmacokinetics and Pharmacodynamics
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-12-31
- First posted
- 2025-05-29
- Last updated
- 2025-05-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06993636. Inclusion in this directory is not an endorsement.