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

NCT04003844 | Completed Phase 4

• 1 other identifier: GC5107E
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 7

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).

Conditions

Kawasaki Disease

Outcome Measures

Primary Outcomes (1)

• incidence of CALs

  incidence of CALs at 7 weeks after treatment

  7 weeks

Secondary Outcomes (22)

• incidence of CALs

  2 weeks

• total duration of fever

  baseline

• laboratory measurements : markers of inflammation and cardiovascular disease

  7 weeks

• laboratory measurements : markers of inflammation and cardiovascular disease

  7 weeks

• laboratory measurements : markers of inflammation and cardiovascular disease

  7 weeks

Study Arms (1)

Experimental

EXPERIMENTAL

Investigational product (IP)

Drug: Immunoglobulin G; Drug: Acetylsalicylic acid

Interventions

Immunoglobulin G DRUG

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

Experimental

Acetylsalicylic acid DRUG

Coadministration

Experimental

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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)
• Subjects with a history of hypersensitivity or shock to IVIG formulations
• Subjects with underlying liver disease or liver dysfunction with known etiology
• Subjects with renal impairment whose creatinine level is more than twice the upper limit of the normal range
• Subjects with a history of malignant tumor
• Subjects with a history of IgA deficiency

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (7)

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Kyung Hee University Medical Center

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

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

Seoul, South Korea

Location

Wonju Severance Christian Hospital

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Immunoglobulin G; Aspirin

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Mi Young Han, MD, Ph.D.

  Kyunghee University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: July 1, 2019
• Study Start: February 1, 2019
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2019
• Last Updated: May 21, 2020

Record last verified: 2020-05

Locations

KR (7)