search
Back to results

Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease

Primary Purpose

Kawasaki Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
immunoglobulin G
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kawasaki Disease

Eligibility Criteria

6 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wonju christian Hospital
  • Gachon University Gil Hospital
  • Asan Medical center
  • Kyung Hee university at Gangdong
  • Kyung Hee university medical center
  • Samsung Medical Center
  • Seoul ST. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Investigational product

Arm Description

Outcomes

Primary Outcome Measures

Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion

Secondary Outcome Measures

Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
Total fever duration
Total fever duration after IVIG-SN infusion
variation of ESR, CRP, NT-proBNP,CK-MB
Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB

Full Information

First Posted
January 25, 2012
Last Updated
September 19, 2012
Sponsor
Green Cross Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01524939
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational product
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
immunoglobulin G
Intervention Description
Intravenously administer a single dose of the product (2g/kg) for at least 12 hours
Primary Outcome Measure Information:
Title
Incidence of coronary artery lesions
Description
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Incidence of coronary artery lesions
Description
Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
Time Frame
2weeks
Title
Total fever duration
Description
Total fever duration after IVIG-SN infusion
Time Frame
baseline
Title
variation of ESR, CRP, NT-proBNP,CK-MB
Description
Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric patients aged 6 months - 5 years Case definition for complete KD: Fever (≥ 38.5°C) for ≥ 5 days (but less than 10 days), 4/5 standard clinical criteria Case definition for incomplete KD: Fever ≥ 5 days(but less than 10 days) and 3 clinical criteria plus coronary artery lesion on echocardiogram. Subjects whose parents or legally acceptable representative (LAR) gave voluntary written consent to participate in this clinical trial Exclusion Criteria: 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. Those who have been administered other clinical product in the last 30 days after this clinical trial commenced Those who have been administered TNF alpha or steroid within 48 hours after being administered the test product Those who plan to be inoculated with live vaccine during the clincial trial period 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.) Those who have been administered an immunosuppressant or immune modifying drug in the last 3 months before the innoculation with the test product Those who are HIV-positive or have immune dysfunctions including immunodeficiency Those who have previously exhibited hypersensitivity or shock to IVIG agents Patients with underlying liver disease or liver dysfunction with known etiology. 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 Those who have -- or previously had -- a malignant tumor Those who have previously been diagnosed with IgA deficiency Those found unsuitable for undergoing the tests
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
June Huh, MD,Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wonju christian Hospital
City
Wonju
State/Province
Kang-won
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee university at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee university medical center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease

We'll reach out to this number within 24 hrs