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

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

Sponsors

Lead Sponsor: Green Cross Corporation

Source Green Cross Corporation
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%.

Overall Status Completed
Start Date February 1, 2019
Completion Date November 22, 2019
Primary Completion Date November 22, 2019
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
incidence of CALs 7 weeks
Secondary Outcome
Measure Time Frame
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
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
laboratory measurements : markers of inflammation and cardiovascular disease 7 weeks
IGIV resistance baseline
adverse events, adverse drug reactions and serious adverse events 7 weeks
laboratory measurements : hematological parameters 7 weeks
laboratory measurements : hematological parameters 7 weeks
laboratory measurements : hematological parameters 7 weeks
laboratory measurements : hematological parameters 7 weeks
laboratory measurements : hematological parameters 7 weeks
laboratory measurements : clinical chemistry parameters 7 weeks
laboratory measurements : clinical chemistry parameters 7 weeks
laboratory measurements : urinalysis 7 weeks
vital signs: blood pressure 7 weeks
vital signs: body temperature 7 weeks
physical examination 7 weeks
Enrollment 45
Condition
Intervention

Intervention Type: Drug

Intervention Name: Immunoglobulin G

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

Arm Group Label: Experimental

Intervention Type: Drug

Intervention Name: Acetylsalicylic acid

Description: Coadministration

Arm Group Label: Experimental

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

Gender: All

Minimum Age: 3 Months

Maximum Age: 12 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mi Young Han, MD, Ph.D. Principal Investigator Kyunghee University Medical Center
Location
Facility:
Hallym University Sacred Heart Hospital | Anyang, Korea, Republic of
Asan Medical Center | Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong | Seoul, Korea, Republic of
Kyung Hee University Medical Center | Seoul, Korea, Republic of
Severance Hospital | Seoul, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, Korea, Republic of
Wonju Severance Christian Hospital | Wonju, Korea, Republic of
Location Countries

Korea, Republic of

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Experimental

Type: Experimental

Description: Investigational product (IP)

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov