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Die klinische Studie NCT07298928 für Wirksamkeit ist noch nicht rekrutierend. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis 30 International Pädiatrisch Offene Studie
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Die klinische Studie NCT07298928 ist eine interventionsstudie zur Untersuchung von Wirksamkeit und hat den Status noch nicht rekrutierend. Der Start ist für 10. März 2026 geplant, bis 30 Teilnehmer aufgenommen werden. Durchgeführt von The Children's Hospital of Zhejiang University School of Medicine wird der Abschluss für 1. Dezember 2028 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 6. März 2026 aktualisiert.
Kurzbeschreibung
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...Mehr anzeigen
Offizieller Titel
The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health
Erkrankungen
WirksamkeitWeitere Studien-IDs
- KYYS-2025-0347
NCT-Nummer
Studienbeginn (tatsächlich)
2026-03-10
Zuletzt aktualisiert
2026-03-06
Studienende (vorauss.)
2028-12
Geplante Rekrutierung
30
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
long-term follow-up
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
Ocular myasthenia gravis
Telitacicept
Children
Biological agent
Targeted treatment
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Experimentella 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...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Zugelassene Geschlechter
Alle
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 MedicineVerantwortliche Partei
Shanshan Mao, Hauptprüfer, Directo, The Children's Hospital of Zhejiang University School of Medicine
Zentrale Studienkontakte
Kontakt: Shanshan Mao, 15990042668, [email protected]
3 Studienstandorte in 1 Ländern
Guangdong
Shenzhen children's Hospital of China Medical University, Shenzhen, Guangdong, China
Xufeng Luo, Kontakt, 19012770239, [email protected]
Shandong
Children's Hospital Affiliated to Shandong University, Jinan, Shandong, China
Kai Ma, Kontakt, 18358628830, [email protected]
Zhejiang
The Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310052, China
Shanshan Mao, Kontakt, 15990042668, [email protected]