Kawasaki DiseasePhase 2/3NCT07686770
Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease
A Phase 2/3 study testing IVIG, Aspirin and Firsekibart in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) . Read more about this study
- Who is it for?
- Ages 29 days to 17 years
- Conditions the study is for
- Kawasaki Disease
- What is being tested?
- IVIG, Aspirin and Firsekibart
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2026to 1 Feb 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 29 days to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
- Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
- Not treated with IVIG yet
- Age >28 days，<18 years
Who cannot join
- Receiving steroids or other immunosuppressive agents in the previous 30 days;
- With a previous history of KD;
- Afebrile before enrolment;
- Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;
- Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients;
- With suspected infectious diseases, such as sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza;
Show all 11Show fewer
- With serious immune diseases, such as immunodeficiency, or chromosomal abnormalities;
- With severe hepatic dysfunction (ALT > 3 times the upper limit of normal) prior to treatment
- Unwillingness to provide written informed consent;
- Unlikely to complete at least 3 months of follow-up;
- Any other conditions deemed unsuitable for enrolment by investigators.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Jiangxi Provincial Children's Hospital
Nanchang, Jiangxi, 330006
Xiaohui Liu, MD
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Fang Liu, MD
About this study
Official title: Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .
Read the detailed description
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.
- Conditions
- Kawasaki Disease
- Being tested
- IVIG, Aspirin, Firsekibart
- Keywords
- Kawasaki Disease, Firsekibart, Coronary Artery Lesion, IVIG-resistant
- 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.
IVIGDrug
Also called Intravenous Immunoglobulins, Human
IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.
AspirinDrug
Also called Acetylsalicylic acid
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.
FirsekibartDrug
Also called Interleukin (IL)-1β receptor antagonist
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.
| Study group | Role | What they receive |
|---|---|---|
| standard treatment group | Active comparator | 【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】
1. IVIG 2g/kg once, given over 8 to 12 hours;
2. 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 C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after illness onset.
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. Receives: Drug: IVIG; Drug: Aspirin |
| Firsekibart + standard treatment group | Experimental | 1. 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.
2. IVIG 2g/kg once, given over 8 to 12 hours;
3. 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.
【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.
In the event of a Grade ≥3 allergic reaction, epinephrine will be administered as needed.
Management of IVIG resistance, aspirin intolerance will be the same as in the control group. Receives: Drug: IVIG; Drug: Aspirin; Drug: Firsekibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: from admission to discharge (about 2 weeks of illness onset)
Secondary outcomes (15)
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.
Measured: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)
Change in serum C-reactive protein (CRP) concentration
Serum CRP levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
Measured: from admission to 1 month of illness onset
Change in Serum Amyloid A (SAA) concentration
SAA levels will be measured at three time points: at enrolment, 72 hours after completion of the initial IVIG infusion, and 1 month of illness onset.
Measured: from admission to 1 month of illness onset
Change in serum interleukin (IL)-1β concentration
Serum IL-1β levels will be measured at two time points: at enrolment, 72 hours after completion of the initial IVIG infusion.
Measured: from admission to 72 hours after completion of the initial IVIG infusion
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.
Measured: 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.
Measured: 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.
Measured: 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).).
Measured: 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).).
Measured: 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).).
Measured: 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).).
Measured: 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).).
Measured: 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).).
Measured: 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.
Measured: 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.
Measured: from admission to 6 months of illness onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
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.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:2 (experimental group: control group)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Province Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Fang Liu, MD, Study director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686770
- Sponsor's protocol ID
- 2026-244
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07686770
- Acronym / sponsor ID
- 2026-244
- Conditions
- Kawasaki Disease
- Keywords
- Kawasaki Disease, Firsekibart, Coronary Artery Lesion, IVIG-resistant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Jiangxi Province Children's Hospital
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 7 Jul 2026 (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.
This study evaluates the efficacy and safety of the addition of Firsekibart to standard initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in children with Acute Kawasaki Disease (KD) .
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:2 (experimental group: control group)
| Arm | Type | Receives |
|---|---|---|
| standard treatment group | Active comparator | Drug: IVIG, Drug: Aspirin【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】 1. IVIG 2g/kg once, given over 8 to 12 hours; 2. 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 C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after illness onset. 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. |
| Firsekibart + standard treatment group | Experimental | Drug: IVIG, Drug: Aspirin, Drug: Firsekibart1. 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. 2. IVIG 2g/kg once, given over 8 to 12 hours; 3. 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. 【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. In the event of a Grade ≥3 allergic reaction, epinephrine will be administered as needed. Management of IVIG resistance, aspirin intolerance will be the same as in the control group. |
Who may qualify
- Ages
- 29 days to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2024
- Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
- Not treated with IVIG yet
- Age >28 days，<18 years
Key exclusion criteria (11 listed)
- Receiving steroids or other immunosuppressive agents in the previous 30 days;
- With a previous history of KD;
- Afebrile before enrolment;
- Contraindications for subcutaneous injection, including severe local skin infection, ulceration, etc;
- Known hypersensitivity to immunoglobulins, Firsekibart, or any of the excipients;
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 |
|---|---|---|
| IVIGAlso: Intravenous Immunoglobulins, HumanIVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g. | Drug | Firsekibart + standard treatment group, standard treatment group |
| AspirinAlso: Acetylsalicylic acidAspirin 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. | Drug | Firsekibart + standard treatment group, standard treatment group |
| FirsekibartAlso: Interleukin (IL)-1β receptor antagonistFirsekibart 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. | Drug | Firsekibart + standard treatment group |
Primary outcome
Occurrence of coronary artery lesions (CAL) at one month of illness
Time frame: from admission to 1 month of illness onset
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.
Occurrence of the need for rescue therapy
Time frame: from admission to discharge (about 2 weeks of illness onset)
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.
15 secondary outcomes
Duration of fever (hours) after initiation of initial IVIG infusion
Time frame: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)
Change in serum C-reactive protein (CRP) concentration
Time frame: from admission to 1 month of illness onset
Change in Serum Amyloid A (SAA) concentration
Time frame: from admission to 1 month of illness onset
Change in serum interleukin (IL)-1β concentration
Time frame: from admission to 72 hours after completion of the initial IVIG infusion
Occurrence of coronary artery lesions (CAL) at 2 weeks of illness
Time frame: from admission to 2 weeks of illness onset
Occurrence of coronary artery lesions (CAL) at 3 months of illness
Time frame: from admission to 3 months of illness onset
Occurrence of medium-to-giant coronary artery aneurysms (CAAs)
Time frame: from admission to 6 months of illness onset
Changes in z scores of LAD
Time frame: from admission to 6 months of illness onset
Changes in z scores of LMCA
Time frame: from admission to 6 months of illness onset
Changes in z scores of LCX
Time frame: from admission to 6 months of illness onset
Changes in z scores of the proximal segment of RCA
Time frame: from admission to 6 months of illness onset
Changes in z scores of the middle segment of RCA
Time frame: from admission to 6 months of illness onset
Occurrence of CAL regression
Time frame: from admission to 6 months of illness onset
Occurrence of CAL progression
Time frame: from admission to 6 months of illness onset
Occurrence of adverse events
Time frame: from admission to 6 months of illness onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Kawasaki Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Kawasaki Disease, Pilot Study
RecruitingObservational study
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
Coronavirus Infection (COVID-19), Pulmonary Arterial Hypertension
RecruitingPhase 4
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Kawasaki Disease, Coronary Artery Aneurysm
RecruitingPhase 3
Statins Study in Children of Acute Kawasaki Disease With Coronary Artery Abnormalities
Kawasaki Disease, Coronary Artery Abnormalities
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.
Fang Liu, MD study director
Children's Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IVIG, Aspirin and Firsekibart in people with Kawasaki Disease, run by Children's Hospital of Fudan University at 2 sites in China.
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 11 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: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Liu, MD (+86 021-64932800, liufang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of coronary artery lesions (CAL) at one month of illness (time frame: from admission to 1 month of illness onset). The study lists 2 primary outcomes in all. 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 22 Oct 2026.