Overview

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

Status:
Withdrawn
Trial end date:
2022-09-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Hospital of Fudan University
Collaborators:
Shanghai 10th People's Hospital
Shanghai Children's Hospital
Shanghai Children's Medical Center
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Treatments:
Aspirin
gamma-Globulins
Immunoglobulins
Immunoglobulins, Intravenous
Infliximab
Rho(D) Immune Globulin
Criteria
Inclusion Criteria:

- Meeting diagnostic criteria for KD released by American Heart Association (AHA) in
2017, including complete KD (also sometimes referred to as typical or classic KD) and
incomplete KD ((also sometimes referred to as atypical KD);

- Diagnosed within 14 days of illness (including the 14th day, considering the first day
of illness as the first day of fever);

- Not treated with IVIG or other treatments for KD yet;

- Z score of any coronary artery of LMCA, LAD, LCX, the proximal and middle segment of
RCA ≥ 2 calculated based on the height, weight and coronary artery diameter measured
by echocardiography;

- Aged between one month and 14 years.

Exclusion Criteria:

- Receiving steroids or other immunosuppressive agents in the previous 30 days;

- With a previous history of KD;

- Afebrile and all the inflammation indicators (including white blood cell count, CRP,
and erythrocyte sedimentation) become normal before enrolment;

- With suspected infectious diseases including tuberculosis, sepsis, septic meningitis,
peritonitis, bacterial pneumonia, varicella, influenza, EBV infection, etc;

- With serious immune diseases such as immunodeficiency or chromosomal abnormalities;

- Unable to be followed up for at least 1 year.