NCT04003844

Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease

Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and IVIG-SN 10% in Pediatric Patients With Kawasaki Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 3 Months – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of high-dose human Immunoglobulin G Intravenous (IGIV) 10% in subjects with Kawasaki diseases (KD).

Detailed description

This is a multicenter, single-arm, and open-label clinical trial to evaluate the coronary artery lesions (CALs) at 2 and 7 weeks after single dose of IGIV 10% (2 g/kg) administration for at least 12 hours to evaluate the efficacy and safety of IGIV 10%.

Conditions

• Kawasaki Disease

Interventions

Type	Name	Description
DRUG	Immunoglobulin G	single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours
DRUG	Acetylsalicylic acid	Coadministration

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-11-22
• Completion: 2019-11-22
• First posted: 2019-07-01
• Last updated: 2020-05-21

Locations

7 sites across 1 country: South Korea