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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04003844
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : May 21, 2020
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Kawasaki Disease Drug: Immunoglobulin G Drug: Acetylsalicylic acid Phase 4

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 1, 2019
Actual Primary Completion Date : November 22, 2019
Actual Study Completion Date : November 22, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kawasaki Disease

Arm Intervention/treatment
Experimental: Experimental
Investigational product (IP)
Drug: Immunoglobulin G
single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours

Drug: Acetylsalicylic acid
Coadministration




Primary Outcome Measures :
  1. incidence of CALs [ Time Frame: 7 weeks ]
    incidence of CALs at 7 weeks after treatment


Secondary Outcome Measures :
  1. incidence of CALs [ Time Frame: 2 weeks ]
    incidence of CALs at 2 weeks after treatment

  2. total duration of fever [ Time Frame: baseline ]
    total duration of fever after treatment

  3. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of erythrocyte sedimentation rate (ESR)

  4. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of C-reactive protein (CRP)

  5. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of N-terminal pro B-type natriuretic peptide (NTproBNP) or B-type natriuretic peptide (BNP)

  6. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of creatine kinase-myocardial band (CK-MB)

  7. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of procalcitonin

  8. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of soluble suppression of tumorigenicity 2 (sST2)

  9. laboratory measurements : markers of inflammation and cardiovascular disease [ Time Frame: 7 weeks ]
    measurement of Troponin I

  10. IGIV resistance [ Time Frame: baseline ]
    frequency of IGIV resistance

  11. adverse events, adverse drug reactions and serious adverse events [ Time Frame: 7 weeks ]
    number of adverse events, adverse drug reactions and serious adverse events

  12. laboratory measurements : hematological parameters [ Time Frame: 7 weeks ]
    measurement of white blood cell (WBC)

  13. laboratory measurements : hematological parameters [ Time Frame: 7 weeks ]
    measurement of red blood cell (RBC)

  14. laboratory measurements : hematological parameters [ Time Frame: 7 weeks ]
    measurement of hemoglobin

  15. laboratory measurements : hematological parameters [ Time Frame: 7 weeks ]
    measurement of hematocrit

  16. laboratory measurements : hematological parameters [ Time Frame: 7 weeks ]
    measurement of platelet count

  17. laboratory measurements : clinical chemistry parameters [ Time Frame: 7 weeks ]
    measurement of alanine transaminase (ALT)

  18. laboratory measurements : clinical chemistry parameters [ Time Frame: 7 weeks ]
    measurement of albumin

  19. laboratory measurements : urinalysis [ Time Frame: 7 weeks ]
    measurement of WBC (urine microscopy)

  20. vital signs: blood pressure [ Time Frame: 7 weeks ]
    measurement of systolic and diastolic blood pressure

  21. vital signs: body temperature [ Time Frame: 7 weeks ]
    measurement of body temperature

  22. physical examination [ Time Frame: 7 weeks ]
    visual inspection of general appearance, head, eyes, nose-mouth-throat, lymph nodes, skin, extremities for abnormal findings



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003844


Locations
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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, Korea, Republic of
Sponsors and Collaborators
Green Cross Corporation
Investigators
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Principal Investigator: Mi Young Han, MD, Ph.D. Kyunghee University Medical Center
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Responsible Party: Green Cross Corporation
ClinicalTrials.gov Identifier: NCT04003844    
Other Study ID Numbers: GC5107E
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
Aspirin
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Immunoglobulin G
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics