Kawasaki DiseasePhase 4NCT04003844
Study of Combined Therapy IVIG-SN 10% and Acetylsalicylic Acid in Kawasaki Disease
A Phase 4 study testing Immunoglobulin G and Acetylsalicylic acid in people with Kawasaki Disease, run by Green Cross Corporation at 7 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- Immunoglobulin G and Acetylsalicylic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 1 Feb 2019to 22 Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
- Subjects with fever 4-10 days meeting one of following criteria (A, B or C)
- Subjects with at least 4 of the following principal clinical findings:
- Bilateral bulbar conjunctival injection without exudate
- Erythema and cracking of lips, strawberry tongue, and/or erythema of oral and pharyngeal mucosa
- Erythema and edema of the hands and feet in acute phase and/or periungual desquamation in subacute phase
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- Cervical lymphadenopathy (≥1.5 cm diameter), usually unilateral
- Rash: maculopapular, diffuse erythroderma, or erythema multiforme-like
- 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
- 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:
- Albumin <3.0 g/dL
- Anemia for age
- Elevated alanine aminotransferase level
- Platelet count of >450,000/mm3 after the 7th day of fever
- White blood cell count of >15,000/mm3
- Urine >10 white blood cells/high-power field
- Subjects whose subject's parents or legally authorized representative gave voluntary written consent to participate in the clinical trial
Who cannot join
- Subjects with a history of KD
- Subjects with following laboratory findings:
- Platelet count <100,000/mm3
- WBC count <3,000 cells/mm3
- hemoglobin, hematocrit or red blood cell count more than 30% above the upper limit or 30% below the lower limit of the normal range
- Subjects who are currently receiving or who have received any investigational drug or device within 30 days prior to administration of the IP
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- Subjects who have received TNF alpha antagonist or systemic corticosteroids within 48 hours prior to administration of the IP
- 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.)
- Subjects who have received immunosuppressive or immunomodulatory drugs within 3 months prior to administration of the IP
- Subjects with immunodeficiency including known positive serology for human immunodeficiency virus (HIV)
- Subjects with a history of hypersensitivity or shock to IVIG formulations
- Subjects with underlying liver disease or liver dysfunction with known etiology
- Subjects with renal impairment whose creatinine level is more than twice the upper limit of the normal range
- Subjects with a history of malignant tumor
- Subjects with a history of IgA deficiency
- Subjects who are considered by the investigator to be an unsuitable candidate for the study for any reason
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Hallym University Sacred Heart Hospital
Anyang
Asan Medical Center
Seoul
Kyung Hee University Hospital at Gangdong
Seoul
Kyung Hee University Medical Center
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
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
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).
Read the 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%.
- Conditions
- Kawasaki Disease
- Being tested
- Immunoglobulin G, Acetylsalicylic acid
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoglobulin GDrug
single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours
Acetylsalicylic acidDrug
Coadministration
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Investigational product (IP) Receives: Drug: Immunoglobulin G; Drug: Acetylsalicylic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CALs
incidence of CALs at 7 weeks after treatment
Measured: 7 weeks
Secondary outcomes (22)
incidence of CALs
incidence of CALs at 2 weeks after treatment
Measured: 2 weeks
total duration of fever
total duration of fever after treatment
Measured: baseline
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of erythrocyte sedimentation rate (ESR)
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of C-reactive protein (CRP)
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of N-terminal pro B-type natriuretic peptide (NTproBNP) or B-type natriuretic peptide (BNP)
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of creatine kinase-myocardial band (CK-MB)
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of procalcitonin
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of soluble suppression of tumorigenicity 2 (sST2)
Measured: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
measurement of Troponin I
Measured: 7 weeks
IGIV resistance
frequency of IGIV resistance
Measured: baseline
adverse events, adverse drug reactions and serious adverse events
number of adverse events, adverse drug reactions and serious adverse events
Measured: 7 weeks
laboratory measurements : hematological parameters
measurement of white blood cell (WBC)
Measured: 7 weeks
laboratory measurements : hematological parameters
measurement of red blood cell (RBC)
Measured: 7 weeks
laboratory measurements : hematological parameters
measurement of hemoglobin
Measured: 7 weeks
laboratory measurements : hematological parameters
measurement of hematocrit
Measured: 7 weeks
laboratory measurements : hematological parameters
measurement of platelet count
Measured: 7 weeks
laboratory measurements : clinical chemistry parameters
measurement of alanine transaminase (ALT)
Measured: 7 weeks
laboratory measurements : clinical chemistry parameters
measurement of albumin
Measured: 7 weeks
laboratory measurements : urinalysis
measurement of WBC (urine microscopy)
Measured: 7 weeks
vital signs: blood pressure
measurement of systolic and diastolic blood pressure
Measured: 7 weeks
vital signs: body temperature
measurement of body temperature
Measured: 7 weeks
physical examination
visual inspection of general appearance, head, eyes, nose-mouth-throat, lymph nodes, skin, extremities for abnormal findings
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Feb 2019
- Primary completion22 Nov 2019
- Study completion22 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kawasaki DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mi Young Han, MD, Ph.D., Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003844
- Sponsor's protocol ID
- GC5107E
- Status last verified
- May 2020
- First submitted
- 16 May 2019
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04003844
- Acronym / sponsor ID
- GC5107E
- Conditions
- Kawasaki Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2019 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Immunoglobulin G, Drug: Acetylsalicylic acidInvestigational product (IP) |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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)
- Subjects with fever 4-10 days meeting one of following criteria (A, B or C)
- Subjects whose subject's parents or legally authorized representative gave voluntary written consent to participate in the clinical trial
Key exclusion criteria (16 listed)
- Subjects with a history of KD
- Subjects with following laboratory findings:
- Subjects who are currently receiving or who have received any investigational drug or device within 30 days prior to administration of the IP
- Subjects who have received TNF alpha antagonist or systemic corticosteroids within 48 hours prior to administration of the IP
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunoglobulin Gsingle dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours | Drug | Experimental |
| Acetylsalicylic acidCoadministration | Drug | Experimental |
Primary outcome
incidence of CALs
Time frame: 7 weeks
incidence of CALs at 7 weeks after treatment
22 secondary outcomes
incidence of CALs
Time frame: 2 weeks
total duration of fever
Time frame: baseline
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
laboratory measurements : markers of inflammation and cardiovascular disease
Time frame: 7 weeks
IGIV resistance
Time frame: baseline
adverse events, adverse drug reactions and serious adverse events
Time frame: 7 weeks
laboratory measurements : hematological parameters
Time frame: 7 weeks
laboratory measurements : hematological parameters
Time frame: 7 weeks
laboratory measurements : hematological parameters
Time frame: 7 weeks
laboratory measurements : hematological parameters
Time frame: 7 weeks
laboratory measurements : hematological parameters
Time frame: 7 weeks
laboratory measurements : clinical chemistry parameters
Time frame: 7 weeks
laboratory measurements : clinical chemistry parameters
Time frame: 7 weeks
laboratory measurements : urinalysis
Time frame: 7 weeks
vital signs: blood pressure
Time frame: 7 weeks
vital signs: body temperature
Time frame: 7 weeks
physical examination
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mi Young Han, MD, Ph.D. principal investigator
Kyunghee University Medical Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immunoglobulin G and Acetylsalicylic acid in people with Kawasaki Disease, run by Green Cross Corporation at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CALs (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.