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

Green Cross Corporation7 sites in 1 country45 target enrollmentFebruary 1, 2019

ConditionsKawasaki Disease

InterventionsImmunoglobulin G Acetylsalicylic acid

DrugsImmunoglobulin G Acetylsalicylic acid

Overview

Phase: Phase 4
Intervention: Immunoglobulin G
Conditions: Kawasaki Disease
Sponsor: Green Cross Corporation
Enrollment: 45
Locations: 7
Primary Endpoint: incidence of CALs
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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%.

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

November 22, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Green Cross Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Infants and children aged 3 months to 7 years inclusive, at the time of signing the informed consent, however, patients with complete KD are eligible up to 12 years (applies to 2A)
•Subjects with fever 4-10 days meeting one of following criteria (A, B or C)
•A. Subjects with at least 4 of the following principal clinical findings:
•i) Bilateral bulbar conjunctival injection without exudate
•ii) Erythema and cracking of lips, strawberry tongue, and/or erythema of oral and pharyngeal mucosa
•iii) Erythema and edema of the hands and feet in acute phase and/or periungual desquamation in subacute phase
•iv) Cervical lymphadenopathy (≥1.5 cm diameter), usually unilateral
•v) Rash: maculopapular, diffuse erythroderma, or erythema multiforme-like
•B. Subjects with at least 3 of the principal clinical findings and coronary artery abnormalities detected by 2-dimensional echocardiography: Z score of left anterior descending coronary artery or right coronary artery ≥2.5
•C. Subjects without coronary artery abnormalities, but with fever ≥5 days, 2 or 3 of the principal clinical findings , CRP of ≥3.0 mg/dL and meeting 3 or more of the following laboratory findings:

Exclusion Criteria

•Subjects with a history of KD
•Subjects with following laboratory findings:
•A. Platelet count \<100,000/mm3
•B. WBC count \<3,000 cells/mm3
•C. hemoglobin, hematocrit or red blood cell count more than 30% above the upper limit or 30% below the lower limit of the normal range
•Subjects who are currently receiving or who have received any investigational drug or device within 30 days prior to administration of the IP
•Subjects who have received TNF alpha antagonist or systemic corticosteroids within 48 hours prior to administration of the IP
•Subjects who are considered by the investigator to be an unsuitable candidate for the study due to a severe chronic disease (e.g. cardiovascular disease except controllable hypertension, respiratory disease with respiratory failure, metabolic disease, renal failure, hemoglobinopathy, etc.)
•Subjects who have received immunosuppressive or immunomodulatory drugs within 3 months prior to administration of the IP
•Subjects with immunodeficiency including known positive serology for human immunodeficiency virus (HIV)

Arms & Interventions

Experimental

Investigational product (IP)

Intervention: Immunoglobulin G

Experimental

Investigational product (IP)

Intervention: Acetylsalicylic acid

Outcomes

Primary Outcomes

incidence of CALs

Time Frame: 7 weeks

incidence of CALs at 7 weeks after treatment

Secondary Outcomes

IGIV resistance(baseline)
vital signs: blood pressure(7 weeks)
vital signs: body temperature(7 weeks)
total duration of fever(baseline)
laboratory measurements : markers of inflammation and cardiovascular disease(7 weeks)
incidence of CALs(2 weeks)
laboratory measurements : hematological parameters(7 weeks)
physical examination(7 weeks)
laboratory measurements : clinical chemistry parameters(7 weeks)
adverse events, adverse drug reactions and serious adverse events(7 weeks)
laboratory measurements : urinalysis(7 weeks)