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

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Brief Title

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

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

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).
    

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%.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

incidence of CALs

Secondary Outcome

 incidence of CALs

Condition

Kawasaki Disease

Intervention

Immunoglobulin G

Study Arms / Comparison Groups

 Experimental
Description:  Investigational product (IP)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

February 1, 2019

Completion Date

November 22, 2019

Primary Completion Date

November 22, 2019

Eligibility 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
      

Gender

All

Ages

3 Months - 12 Years

Accepts Healthy Volunteers

No

Contacts

Mi Young Han, MD, Ph.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT04003844

Organization ID

GC5107E


Responsible Party

Sponsor

Study Sponsor

Green Cross Corporation


Study Sponsor

Mi Young Han, MD, Ph.D., Principal Investigator, Kyunghee University Medical Center


Verification Date

May 2020