治験レーダーAI | ||
|---|---|---|
治験 NCT07298928（対象：有効性）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
1件の試験がフィルター基準に一致しました
タイル表示
A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis 30 国際共同 小児 非盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07298928 は 介入研究 臨床試験 で、有効性 に関するものです。現在は 募集準備中 で、2026年3月10日 に開始予定です。30 名の参加者 の募集が計画されています。この試験は The Children's Hospital of Zhejiang University School of Medicine によって主導され、2028年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月6日 です。
概要
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...もっと見る
公式タイトル
The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health
疾患名
有効性その他の研究識別子
- KYYS-2025-0347
NCT番号
開始日
2026-03-10
最終更新日
2026-03-06
終了予定日
2028-12
目標参加者数
30
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
long-term follow-up
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的a 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...もっと見る |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
小児, 成人
対象性別
全て
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 Medicine責任者
Shanshan Mao, 主任研究者, Directo, The Children's Hospital of Zhejiang University School of Medicine
試験中央連絡先
連絡先: Shanshan Mao, 15990042668, [email protected]
3 1カ国の場所
Guangdong
Shenzhen children's Hospital of China Medical University, Shenzhen, Guangdong, China
Xufeng Luo, 連絡先, 19012770239, [email protected]
Shandong
Children's Hospital Affiliated to Shandong University, Jinan, Shandong, China
Kai Ma, 連絡先, 18358628830, [email protected]
Zhejiang
The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310052, China
Shanshan Mao, 連絡先, 15990042668, [email protected]