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

NCT ID: NCT04003844

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2019-11-22

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%.

Conditions

Kawasaki Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Investigational product (IP)

Group Type: EXPERIMENTAL

Immunoglobulin G

Intervention Type: DRUG

single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours

Acetylsalicylic acid

Intervention Type: DRUG

Coadministration

Interventions

Immunoglobulin G

single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours

Intervention Type: DRUG

Acetylsalicylic acid

Coadministration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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)

2. 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:

i) Albumin <3.0 g/dL

ii) Anemia for age

iii) Elevated alanine aminotransferase level

iv) Platelet count of >450,000/mm3 after the 7th day of fever

v) White blood cell count of >15,000/mm3

vi) Urine >10 white blood cells/high-power field

3. Subjects whose subject's parents or legally authorized representative gave voluntary written consent to participate in the clinical trial

Exclusion Criteria

1. Subjects with a history of KD

2. 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

3. Subjects who are currently receiving or who have received any investigational drug or device within 30 days prior to administration of the IP

4. Subjects who have received TNF alpha antagonist or systemic corticosteroids within 48 hours prior to administration of the IP

5. 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.)

6. Subjects who have received immunosuppressive or immunomodulatory drugs within 3 months prior to administration of the IP

7. Subjects with immunodeficiency including known positive serology for human immunodeficiency virus (HIV)

8. Subjects with a history of hypersensitivity or shock to IVIG formulations

9. Subjects with underlying liver disease or liver dysfunction with known etiology

10. Subjects with renal impairment whose creatinine level is more than twice the upper limit of the normal range

11. Subjects with a history of malignant tumor

12. Subjects with a history of IgA deficiency

13. Subjects who are considered by the investigator to be an unsuitable candidate for the study for any reason

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mi Young Han, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Locations

Hallym University Sacred Heart Hospital

Anyang, , South Korea

Asan Medical Center

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Kyung Hee University Medical Center

Seoul, , South Korea

Severance Hospital

Seoul, , South Korea

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, , South Korea

Wonju Severance Christian Hospital

Wŏnju, , South Korea

Countries

South Korea

Other Identifiers

GC5107E

Identifier Type: -

Identifier Source: org_study_id