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Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

NCT06993636 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-05-29

No results posted yet for this study

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Fang Liu, MD · Children's Hospital of Fudan University

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT06993636 on ClinicalTrials.gov