Clinical trial NCT01524939: Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
Official title: Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kawasaki Disease
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 45
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.

Detailed description: This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.

Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients aged 6 months - 5 years
2. Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria
3. Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram.
4. Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial

Exclusion Criteria:

1. Those whose blood test results show abnormalities of significance as follows : Platelet count \< 100,000/mm3, WBC count \<3,000 cells/mm3,Those whose hemogloblin, hematocrit or red blood cell count exceed 30% of the upper limit of the normal range or are 30% below the lower limit of the normal range.
2. Those who have been administered other clinical product in the last 30 days after this clinical trial commenced
3. Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product
4. Those who plan to be inoculated with live vaccine during the clincial trial period
5. Those considered difficult to participate in clinical trial due to serious chronic diseases(e.g., cardiovascular diseases except controllable hypertension, diseases of the respiratory system concurrent with respiratory failure, metabolic disease, kidney dysfunction, hemoglobinopathy, etc.)
6. Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product
7. Those who are HIV-positive or have immune dysfunctions including immunodeficiency
8. Those who have previously exhibited hypersensitivity or shock to IVIG agents
9. Patients with underlying liver disease or liver dysfunction with known etiology.
10. Patients with kidney dysfunction, whose Creatinine level is found to be over 2 times higher than the upper limit of the normal ranges in a screening test
11. Those who have -- or previously had -- a malignant tumor
12. Those who have previously been diagnosed with IgA deficiency
13. Those found unsuitable for undergoing the tests

Primary outcomes:
measure: Incidence of coronary artery lesions
timeFrame: 7 weeks
Secondary outcomes:
measure: Incidence of coronary artery lesions
timeFrame: 2weeks
measure: Total fever duration
timeFrame: baseline
measure: variation of ESR, CRP, NT-proBNP,CK-MB
timeFrame: baseline
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju christian Hospital
state: Kang-won
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee university at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kyung Hee university medical center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul ST. Mary's Hospital
Study officials:
affiliation: Samsung Medical Center
name: June Huh, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: