Multicenter, Single-Arm, Phase IV Study of Combined Aspirin and High-Dose "IVIG-SN" Therapy for Pediatric Patients with Kawasaki Disease.

ABSTRACT:

Background and objectives

Intravenous immunoglobulin-SN (IVIG-SN) is a new human immunoglobulin product. Its safety is ensured by pathogen-elimination steps comprising solvent/detergent treatment and a nanofiltration process. This multicenter clinical study was designed to evaluate the efficacy and safety of combined aspirin and high-dose IVIG-SN therapy in pediatric patients with Kawasaki disease (KD).

Subjects and methods

We evaluated coronary artery lesions (CALs) at 2 and 7 weeks after administering IVIG-SN; total fever duration; and variations in erythrocyte sedimentation rate, N-terminal pro B-type natriuretic peptide or B-type natriuretic peptide, and creatine kinase-myocardial band level before and after treatment with IVIG-SN (2 g/kg). Adverse events were monitored.

SUBMITTER: Yoon KL 

PROVIDER: S-EPMC5378027 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature