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Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

NCT04535518 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-03-12

No results posted yet for this study

Summary

This study evaluates the efficacy of the addition of infliximab to conventional initial treatment (intravenous immunoglobulin \[IVIG\] plus aspirin) in early regression of coronary artery lesion in patients with Kawasaki disease (KD).

Conditions

  • Kawasaki Disease

Interventions

DRUG

IVIG

IVIG at a single dose of 2 g/kg

DRUG

Aspirin

Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 72 hours and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

DRUG

Infliximab

Intravenous infliximab at single dose of 5 mg/kg, given more than 2 hours.

Sponsors & Collaborators

  • Shanghai Children's Hospital

    collaborator OTHER

  • Shanghai Children's Medical Center

    collaborator OTHER

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai 10th People's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Guoying Huang, MD. · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-31
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04535518 on ClinicalTrials.gov