Kawasaki DiseasePhase 4NCT01524939
Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
A Phase 4 study testing immunoglobulin G 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 safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- immunoglobulin G
- 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
- Jan 2012to Sep 2012
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Gachon University Gil Hospital
Incheon
Asan Medical center
Seoul
Kyung Hee university at Gangdong
Seoul
Kyung Hee university medical center
Seoul
Samsung Medical Center
Seoul
Seoul ST. Mary's Hospital
Seoul
Wonju christian Hospital
Wŏnju, Kang-won, 220-701
About this study
Official title: Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Disease
The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
Read the detailed description
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.
- Conditions
- Kawasaki Disease
- Being tested
- immunoglobulin G
- 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
Intravenously administer a single dose of the product (2g/kg) for at least 12 hours
| Study group | Role | What they receive |
|---|---|---|
| Investigational product | Experimental | Not described Receives: Drug: immunoglobulin G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion
Measured: 7 weeks
Secondary outcomes (3)
Incidence of coronary artery lesions
Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
Measured: 2weeks
Total fever duration
Total fever duration after IVIG-SN infusion
Measured: baseline
variation of ESR, CRP, NT-proBNP,CK-MB
Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
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
- June Huh, MD,Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524939
- Sponsor's protocol ID
- IVIG-SN_KD_P4
- Status last verified
- Jan 2012
- First submitted
- 25 Jan 2012
- Last updated
- 20 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2012. 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 High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Disease
- ClinicalTrials.gov ID
- NCT01524939
- Acronym / sponsor ID
- IVIG-SN_KD_P4
- 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
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 2 Feb 2012 (estimated)
- 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 safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
Detailed description
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational product | Experimental | Drug: immunoglobulin G |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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.)
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 GIntravenously administer a single dose of the product (2g/kg) for at least 12 hours | Drug | Investigational product |
Primary outcome
Incidence of coronary artery lesions
Time frame: 7 weeks
Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion
3 secondary outcomes
Incidence of coronary artery lesions
Time frame: 2weeks
Total fever duration
Time frame: baseline
variation of ESR, CRP, NT-proBNP,CK-MB
Time frame: baseline
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 20 Sep 2012.
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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.
June Huh, MD,Ph.D principal investigator
Samsung 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 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 4 inclusion and 13 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 20 Sep 2012. 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 coronary artery lesions (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 20 Sep 2012.