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| Name | Class |
|---|---|
| Jiangxi Province Children's Hospital | OTHER |
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This study evaluates the efficacy and safety of the addition of Firsekibart to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .
This is a two-center, open-label, randomized controlled exploratory clinical trial in China. The investigators will enroll KD pediatric patients within 10 days of illness onset. Participants will be randomly assigned in a 1:2 ratio to the experimental group (receiving 3 mg/kg Firsekibart plus 2 g/kg IVIG and 30 mg/kg aspirin) or the control group (receiving 2 g/kg IVIG and 30 mg/kg aspirin). Baseline characteristics of each participant will be collected, including sex, age at onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, and 6 months after illness onset to assess the coronary artery lesions. This study aims to determine the therapeutic potential of standard therapy combined with Firsekibart in the acute phase of KD for reducing the incidence of coronary artery lesions (CAL) , decreasing IVIG resistance, and improving inflammation control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard treatment group | Active Comparator | 【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】
Participants with persistent or recurrent fever (temperature of ≥38°C ) 36 hours after completion of the first IVIG infusion are defined as having resistance to IVIG and will receive rescue therapy. The rescue therapy will be chosen on the basis of participant's condition and the physician's experience. Participants intolerant to aspirin may receive oral clopidogrel as an alternative. In the event of a Grade ≥3 allergic reaction, the treatment will be discontinued immediately, and epinephrine will be administered. |
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| Firsekibart + standard treatment group | Experimental |
【Standard treatment also follow the 2024 AHA Guidelines of Kawasaki Disease】 Discomfort occurring during the observation period after Firsekibart will be treated symptomatically, and standard treatment will subsequently be provided as needed based on the participant's condition and the physician's experience. Management of IVIG resistance, aspirin intolerance , and allergic reaction will be the same as in the control group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVIG | Drug | IVIG 2g/kg once, given within 8 to 12 hours, with the maximum dose of 60g. |
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| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of coronary artery lesions (CAL) at one month of illness | Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. | from admission to 1 month of illness onset |
| Occurrence of the need for rescue therapy | Temperature will be measured every 6 hours a day during hospitalization. Participants who have recurrent or persistent fever (temperature ≥38°C) after 36 hours of completion of initial IVIG infusion will be given rescue therapy. | from admission to discharge (about 2 weeks of illness onset) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of fever (hours) after initiation of initial IVIG infusion | Temperature will be measured every 6 hours a day during hospitalization. Participants with temperature <37.5℃ for more than 24 hours are considered afebrile. Record the time of the initiation of IVIG infusion and the time of the body temperature first becoming normal. | from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Liu, MD | Contact | +86 021-64932800 | liufang@fudan.edu.cn | |
| Lan He, MD | Contact | +8602164932026 | helan0361@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Liu, MD | Children's Hospital of Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangxi Provincial Children's Hospital | Nanchang | Jiangxi | 330006 | China |
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| ID | Term |
|---|---|
| D009080 | Mucocutaneous Lymph Node Syndrome |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D001241 | Aspirin |
| D007378 | Interleukins |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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1:2 (experimental group: control group)
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Participants and physicians will not be masked to the assignment. Outcome assessors (i.e., echocardiographers) and statisticians will be unaware of the assignments throughout the trial until completion of the statistical analysis.
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| Aspirin | Drug | Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness. |
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| Firsekibart | Drug | Firsekibart 3 mg/kg by a single subcutaneous injection prior to IVIG infusion. After a 30-minute observation period confirming the absence of adverse reactions, the IVIG infusion is initiated. |
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| Change in serum C-reactive protein (CRP) concentration | Serum CRP levels will be measured at four time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 2 weeks and 1 month of illness onset. | from admission to 1 month of illness onset |
| Change in Serum Amyloid A (SAA) concentration | SAA levels will be measured at four time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 2 weeks and 1 month of illness onset. | from admission to 1 month of illness onset |
| Change in serum interleukin (IL)-1β concentration | Serum IL-1β levels will be measured at four time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 2 weeks and 1 month of illness onset. | from admission to 1 month of illness onset |
| Occurrence of coronary artery lesions (CAL) at 2 weeks of illness | Two-dimensional echocardiography will be performed to evaluate CAL at 2 weeks of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. | from admission to 2 weeks of illness onset |
| Occurrence of coronary artery lesions (CAL) at 3 months of illness | Two-dimensional echocardiography will be performed to evaluate CAL at 3 months of illness. Measurements for each patient include the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated (Journal of the American Society of Echocardiography, 2011, 24(1).). CAL is defined as z≥2.5 of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA. | from admission to 3 months of illness onset |
| Occurrence of medium-to-giant coronary artery aneurysms (CAAs) | This is a repeatedly measured binary variable. CAL classification is based on the maximum Z score according to the 2024 American Heart Association guideline. Medium CAAs is defined as a maximum Z score ≥5 to <10, and all internal diameters <8 mm; large or giant CAAs defined as a maximum Z score ≥10, or any internal diameter ≥8 mm. | from admission to 6 months of illness onset |
| Changes in z scores of LAD | This is a repeated measurement. The internal diameter of LAD will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Changes in z scores of LMCA | This is a repeated measurement. The internal diameter of LMCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Changes in z scores of LCX | This is a repeated measurement. The internal diameter of LCX will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Changes in z scores of the proximal segment of RCA | This is a repeated measurement. The internal diameter of the proximal segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Changes in z scores of the middle segment of RCA | This is a repeated measurement. The internal diameter of the middle segment of RCA will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months of illness. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Occurrence of CAL regression | CAL regression is defined as Z score <2.5 in any coronary artery (LMCA, LAD, LCX, and the proximal and middle segments of the RCA), with no stenotic or occlusive lesions present.The internal diameter of the coronary artery will be measured by echocardiography at five time points: at enrolment, at 2 weeks, 1 month, 3 months and 6 months after illness onset. Z score will be calculated based on the height, weight and coronary artery diameter (Journal of the American Society of Echocardiography, 2011, 24(1).). | from admission to 6 months of illness onset |
| Occurrence of CAL progression | CAL progression is defined as an increment in the Z score >1 from admission in any coronary artery (LMCA, LAD, LCX, proximal and middle segments of RCA) at any given time point within 6 months of illness onset. The outcome will be assessed in all participants and those with CAL at baseline. | from admission to 6 months of illness onset |
| Occurrence of adverse events | This is a composite outcome, including (a) clinical adverse events (death, severe infection, allergic reactions, heart failure, and thrombosis); (b) laboratory abnormalities (neutropenia, defined as <1.5×10⁹/L; thrombocytopenia, defined as <100×10⁹/L; newly developed ALT abnormality after medication, or further elevation of abnormal baseline ALT); (c) infectious events (occurrence of bacterial/viral infections); and (d) injection-site allergic reactions (redness and swelling at the injection site, rash, and anaphylactic shock) , etc. | from admission to 6 months of illness onset |
| Children's Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
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| D006425 |
| Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |