Aspirin 및 Firsekibart 및 IVIG의 가와사키병 - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

가와사키병

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

90

단계

2 단계
3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Fang Liu, MD
전화번호: +86 021-64932800
이메일: liufang@fudan.edu.cn

연구 연락처 백업

이름: Lan He, MD
전화번호: +8602164932026
이메일: helan0361@163.com

연구 장소

중국
- Jiangxi
  - Nanchang, Jiangxi, 중국, 330006
    - Jiangxi Provincial Children's Hospital
    - 연락하다:
      
      Xiaohui Liu, MD
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, 중국, 201102
    - Children's Hospital of Fudan University
    - 연락하다:
      
      Fang Liu, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

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

Exclusion Criteria:

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 including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza, etc;
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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

주 목적: 치료
할당: 무작위
중재 모델: 병렬 할당
마스킹: 하나의

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
활성 비교기: standard treatment group 【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】 IVIG 2g/kg once, given over 8 to 12 hours; 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.	의약품: Aspirin 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. 다른 이름들: 아세틸 살리실산 의약품: IVIG IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g. 다른 이름들: 정맥 면역 글로불린, 인간
실험적: Firsekibart + standard treatment group 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. IVIG 2g/kg once, given over 8 to 12 hours; 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.	의약품: Aspirin 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. 다른 이름들: 아세틸 살리실산 의약품: Firsekibart 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. 다른 이름들: Interleukin (IL)-1β receptor antagonist 의약품: IVIG IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g. 다른 이름들: 정맥 면역 글로불린, 인간

참가자 그룹 / 팔

개입 / 치료

활성 비교기: standard treatment group

【Standard treatment follow the 2024 AHA Guidelines of Kawasaki Disease】

IVIG 2g/kg once, given over 8 to 12 hours;
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.

의약품: Aspirin

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.

다른 이름들:

아세틸 살리실산

의약품: IVIG

IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.

다른 이름들:

정맥 면역 글로불린, 인간

실험적: Firsekibart + standard treatment group

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.
IVIG 2g/kg once, given over 8 to 12 hours;
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.

의약품: Aspirin

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.

다른 이름들:

아세틸 살리실산

의약품: Firsekibart

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.

다른 이름들:

Interleukin (IL)-1β receptor antagonist

의약품: IVIG

IVIG 2g/kg once, given over 8 to 12 hours, with the maximum dose of 60g.

다른 이름들:

정맥 면역 글로불린, 인간

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Occurrence of coronary artery lesions (CAL) at one month of illness 기간: 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.	from admission to 1 month of illness onset
Occurrence of the need for rescue therapy 기간: 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.	from admission to discharge (about 2 weeks of illness onset)

2차 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Hospital of Fudan University

협력자

Jiangxi Province Children's Hospital

수사관

연구 책임자: Fang Liu, MD, Children's Hospital of Fudan University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 1일

기본 완료 (추정된)

2027년 9월 1일

연구 완료 (추정된)

2028년 2월 1일

연구 등록 날짜

최초 제출

2026년 6월 26일

QC 기준을 충족하는 최초 제출

2026년 7월 6일

처음 게시됨 (실제)

2026년 7월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 24일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

2026-244

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결과 측정	측정값 설명	기간
Duration of fever (hours) after initiation of initial IVIG infusion 기간: from initiation of the initial IVIG infusion to the first recorded afebrile status (up to 60 hours after the infusion of IVIG)	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)
Occurrence of coronary artery lesions (CAL) at 2 weeks of illness 기간: from admission to 2 weeks of illness onset	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 기간: from admission to 3 months of illness onset	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) 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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 기간: from admission to 6 months of illness onset	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
Change in serum C-reactive protein (CRP) concentration 기간: from admission to 1 month of illness onset	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.	from admission to 1 month of illness onset
Change in Serum Amyloid A (SAA) concentration 기간: from admission to 1 month of illness onset	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.	from admission to 1 month of illness onset
Change in serum interleukin (IL)-1β concentration 기간: from admission to 72 hours after completion of the initial IVIG infusion	Serum IL-1β levels will be measured at two time points: at enrolment, 72 hours after completion of the initial IVIG infusion.	from admission to 72 hours after completion of the initial IVIG infusion

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

연구 연락처 백업

연구 장소

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

협력자

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (추정된)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구