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

Kawasaki Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04003844
• Other study ID #: GC5107E
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2019
• Est. completion date: November 22, 2019

Study information

• Verified date: May 2020
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Kawasaki Disease
• Mucocutaneous Lymph Node Syndrome

Intervention

Drug:
• Immunoglobulin G
single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours
• Acetylsalicylic acid
Coadministration

Locations

Country	Name	City	State
Korea, Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of CALs	incidence of CALs at 7 weeks after treatment	7 weeks
Secondary	incidence of CALs	incidence of CALs at 2 weeks after treatment	2 weeks
Secondary	total duration of fever	total duration of fever after treatment	baseline
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of erythrocyte sedimentation rate (ESR)	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of C-reactive protein (CRP)	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of N-terminal pro B-type natriuretic peptide (NTproBNP) or B-type natriuretic peptide (BNP)	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of creatine kinase-myocardial band (CK-MB)	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of procalcitonin	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of soluble suppression of tumorigenicity 2 (sST2)	7 weeks
Secondary	laboratory measurements : markers of inflammation and cardiovascular disease	measurement of Troponin I	7 weeks
Secondary	IGIV resistance	frequency of IGIV resistance	baseline
Secondary	adverse events, adverse drug reactions and serious adverse events	number of adverse events, adverse drug reactions and serious adverse events	7 weeks
Secondary	laboratory measurements : hematological parameters	measurement of white blood cell (WBC)	7 weeks
Secondary	laboratory measurements : hematological parameters	measurement of red blood cell (RBC)	7 weeks
Secondary	laboratory measurements : hematological parameters	measurement of hemoglobin	7 weeks
Secondary	laboratory measurements : hematological parameters	measurement of hematocrit	7 weeks
Secondary	laboratory measurements : hematological parameters	measurement of platelet count	7 weeks
Secondary	laboratory measurements : clinical chemistry parameters	measurement of alanine transaminase (ALT)	7 weeks
Secondary	laboratory measurements : clinical chemistry parameters	measurement of albumin	7 weeks
Secondary	laboratory measurements : urinalysis	measurement of WBC (urine microscopy)	7 weeks
Secondary	vital signs: blood pressure	measurement of systolic and diastolic blood pressure	7 weeks
Secondary	vital signs: body temperature	measurement of body temperature	7 weeks
Secondary	physical examination	visual inspection of general appearance, head, eyes, nose-mouth-throat, lymph nodes, skin, extremities for abnormal findings	7 weeks