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Активно (без набиране) Фаза 3 NCT05644561

Evaluation of PK, PD, Efficacy, Safety, and Immunogenicity of IV Ravulizumab in Pediatric Participants With Generalized Myasthenia Gravis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Generalized Myasthenia Gravis gMG

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The primary purpose of this study is to characterize the pharmacokinetics and pharmacodynamics of treatment with ravulizumab intravenous infusion in pediatric participants with gMG.
Кой може да участва
Inclusion Criteria: * Diagnosis of gMG confirmed by a positive serologic test for anti-AChR antibodies (Abs) obtained at Screening and/or during Screening Period * Myasthenia Gravis Foundation of America (MGFA) Clinical Classification of Class II to Class IV at Screening * Participants receiving treatment must be on a stable dosing regimen of adequate duration prior to Screening and during the Screening Period. * Eculizumab-experienced participants must have been enrolled and treated with eculizumab in Study ECU-MG-303 for at least 6 months (180 days) and must have been on a stable dose for ≥ 2 months (60 days) prior to Screening. * All participants must be vaccinated against meningococcal infection Exclusion Criteria: Medical Conditions * Any untreated thymic malignancy, carcinoma, or thymoma. * Participants with a history of treated benign thymoma * History of thymectomy, thymomectomy, or any thymic surgery within the 12 months prior to Screening * History of N meningitidis infection * Known to be human immunodeficiency virus (HIV) positive * History of unexplained infections * Known or suspected history of drug or alcohol abuse or dependence within 1 year prior to the start of the Screening Period
Интервенции
Ravulizumab
DRUG
Места на провеждане 11
Италия (3)
Research Site
Milan
Research Site
Roma
Research Site
Torino
Япония (1)
Research Site
Itabashi-ku
Сърбия (2)
Research Site
Belgrade
Research Site
Belgrade
Швейцария (1)
Research Site
Bern
САЩ (4)
Research Site
Boston , Massachusetts
Research Site
Chapel Hill , North Carolina
Research Site
Los Angeles , California
Research Site
Philadelphia , Pennsylvania
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
24.06.2023
Крайна дата
30.06.2028
Регистрационен номер
NCT05644561
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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