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임상시험 NCT07298928은(는) 효과에 대해 대상자모집전 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis 30 국제 소아 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07298928은(는) 효과에 대해 알아보는 중재연구입니다. 현재 상태는 대상자모집전이며, 2026년 3월 10일부터 참여 신청이 가능합니다. 30명의 참여자를 모집할 예정입니다. The Children's Hospital of Zhejiang University School of Medicine이(가) 진행하는 이 연구는 2028년 12월 1일까지 진행될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 6일에 갱신되었습니다.
간단한 개요
Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in nat...더 보기
공식 제목
The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health
질환명
효과기타 연구 식별자
- KYYS-2025-0347
NCT 번호
실제 연구 시작일
2026-03-10
최신 업데이트 게시
2026-03-06
예상 연구 완료일
2028-12
계획된 등록 인원
30
연구종류
중재연구
단계/상
해당 없음
상태
대상자모집전
키워드
long-term follow-up
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적a single Telitacicept treatment group | Telitacicept All enrolled pediatric patients with OMG who meet the inclusion criteria will receive subcutaneous injections of Telitacicept on top of their existing medication regimen. The dose will be adjusted according to the patient's body weight: 160 mg per dose for those weighing ≥40 kg; 80 mg per dose for those weighing between 20 kg and \<40 kg; for patients weighing \<20 kg or aged \<5 years, a gradual dose reduction may b...더 보기 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Ocular Myasthenia Gravis Rating Scale-q Score | This Ocular Myasthenia Gravis Rating Scale (OMGRate) is used to assess the impact of symptoms on the quality of daily life in patients with OMG. The OMGRate-q section of the scale is the patient - reported outcome component for evaluating the improvement of self - perceived symptoms. The questionnaire is completed based on the patient's condition over the past 2 weeks.
The total score ranges from 0 to 52 points, with higher scores indicating more severe symptoms and greater impairment of daily quality of life. | baseline, 1 week, 2 week,3 week,4 week,6 week, 8 week, 10 week,12 week, 16 week, 20 week, 24 week |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
quantitative Myasthenia Gravis scale | This scale is a standardized tool for the objective measurement of muscle strength and endurance in MG-affected muscle groups. It consists of 13 items covering the following aspects: eyes (onset time of diplopia and ptosis), facial muscles (lip closure strength), pharynx and larynx (swallowing and pronunciation tests), respiration (percentage of forced vital capacity relative to the predicted value), neck (duration of head lifting while lying supine), hand strength (strength reduction measured by a dynamometer), and limbs (duration of posture maintenance).
Each item is scored on a 4-point scale: 0 (normal), 1 (mild), 2 (moderate), and 3 (severe), with a total score ranging from 0 to 39. Higher scores indicate more severe symptoms. | baseline, 1 week, 2 week,3 week,4 week,6 week, 8 week, 10 week,12 week, 16 week, 20 week, 24 week |
Myasthenia Gravis⁃activity of daily living scale | This scale is mainly used to assess the impact of symptoms on the quality of daily life in patients with MG and reflect the severity of the disease.
It includes 8 items covering 4 aspects: eyes (frequency of ptosis and diplopia), bulbar region (degree of involvement in speech, chewing, and swallowing), respiration (relationship between breathing and physical activity), and limbs (ability to complete daily movements).
Each item is scored on a scale of 0 (normal) to 3 (most severe), with a total score ranging from 0 to 24. Higher scores indicate greater disease severity. | baseline, 1 week, 2 week,3 week,4 week,6 week, 8 week, 10 week,12 week, 16 week, 20 week, 24 week |
Number and proportion of children patients who have their hormone therapy discontinued | 8 week, 16 week, 24 week | |
The incidence and severity of adverse events | baseline, 4 week, 8 week, 12 week, 24 week |
참여 도우미
적격성 기준
연령대
어린이, 성인
참여 가능한 성별
전체
The patient and their legal guardian voluntarily sign the informed consent form.
Age < 18 years, male or female.
Diagnosis of OMG according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition).
Stable administration of any one or combination of the following standard treatments prior to enrollment:
- Cholinesterase inhibitors
- Glucocorticoids
- Active infection under treatment： Patients who are HBsAg positive must be excluded. Patients who are HBsAg negative but HBcAb positive must undergo quantitative HBV-DNA testing. Patients with a positive quantitative HBV-DNA result must be excluded; those with a negative result may be enrolled.
- Severe hepatic or renal insufficiency.
- Patients with malignant tumors other than thymoma.
- Patients within 3 months post-thymectomy.
- Hypogammaglobulinemia (IgG < 400 mg/dL) or IgA deficiency (IgA < 10 mg/dL).
- History of allergy to human-derived biological products.
- Participation in any other clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug from the previous trial (whichever is longer).
- Patients deemed unsuitable for participation by the investigator (e.g., patients with severe psychiatric disorders).
The Children's Hospital of Zhejiang University School of Medicine연구 책임자
Shanshan Mao, 책임연구자, Directo, The Children's Hospital of Zhejiang University School of Medicine
연구 대표 연락처
연락처: Shanshan Mao, 15990042668, [email protected]
3 1개국에 임상시험 장소
Guangdong
Shenzhen children's Hospital of China Medical University, Shenzhen, Guangdong, China
Xufeng Luo, 연락처, 19012770239, [email protected]
Shandong
Children's Hospital Affiliated to Shandong University, Jinan, Shandong, China
Kai Ma, 연락처, 18358628830, [email protected]
Zhejiang
The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310052, China
Shanshan Mao, 연락처, 15990042668, [email protected]