Clinical trial NCT04003844: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kawasaki Disease
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2019-07-01
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
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 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%.

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

Primary outcomes:
measure: incidence of CALs
timeFrame: 7 weeks
Secondary outcomes:
measure: incidence of CALs
timeFrame: 2 weeks
measure: total duration of fever
timeFrame: baseline
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: laboratory measurements : markers of inflammation and cardiovascular disease
timeFrame: 7 weeks
measure: IGIV resistance
timeFrame: baseline
measure: adverse events, adverse drug reactions and serious adverse events
timeFrame: 7 weeks
measure: laboratory measurements : hematological parameters
timeFrame: 7 weeks
measure: laboratory measurements : hematological parameters
timeFrame: 7 weeks
measure: laboratory measurements : hematological parameters
timeFrame: 7 weeks
measure: laboratory measurements : hematological parameters
timeFrame: 7 weeks
measure: laboratory measurements : hematological parameters
timeFrame: 7 weeks
measure: laboratory measurements : clinical chemistry parameters
timeFrame: 7 weeks
measure: laboratory measurements : clinical chemistry parameters
timeFrame: 7 weeks
measure: laboratory measurements : urinalysis
timeFrame: 7 weeks
measure: vital signs: blood pressure
timeFrame: 7 weeks
measure: vital signs: body temperature
timeFrame: 7 weeks
measure: physical examination
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St. Mary's Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Kyunghee University Medical Center
name: Mi Young Han, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: