NCT01524939

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 20, 2012

Status Verified

January 1, 2012

Enrollment Period

8 months

First QC Date

January 25, 2012

Last Update Submit

September 19, 2012

Conditions

Kawasaki Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of coronary artery lesions

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

    7 weeks

Secondary Outcomes (3)

  • Incidence of coronary artery lesions

    2weeks

  • Total fever duration

    baseline

  • variation of ESR, CRP, NT-proBNP,CK-MB

    baseline

Study Arms (1)

Investigational product

EXPERIMENTAL
Drug: immunoglobulin G

Interventions

immunoglobulin GDRUG

Intravenously administer a single dose of the product (2g/kg) for at least 12 hours

Investigational product

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Wonju christian Hospital

Wŏnju, Kang-won, 220-701, South Korea

Location

Gachon University Gil Hospital

Incheon, South Korea

Location

Asan Medical center

Seoul, South Korea

Location

Kyung Hee university at Gangdong

Seoul, South Korea

Location

Kyung Hee university medical center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Interventions

Immunoglobulin G

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • June Huh, MD,Ph.D

    Samsung 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

January 25, 2012

First Posted

February 2, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

September 20, 2012

Record last verified: 2012-01

Locations

KR(7)