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Активно (без набиране) Фаза 3 NCT04042025

Long-term Follow-up Study of Patients Receiving Onasemnogene Abeparvovec-xioi

Фаза 3 – широко изпитване преди одобрение
Заболявания: Spinal Muscular Atrophy Type I Spinal Muscular Atrophy Type II Spinal Muscular Atrophy Type III SMA

Спонсор: Novartis Gene Therapies

Налично на: БГ
Обобщение
This is a long-term follow-up safety and efficacy study of participants in clinical trials for spinal muscular atrophy (SMA) who were treated with onasemnogene abeparvovec-xioi. Participants will roll over from their respective previous (parent) study into this long-term study for continuous monitoring of safety as well as monitoring of continued efficacy and durability of response to onasemnogene abeparvovec-xioi treatment.
Кой може да участва
Inclusion Criteria: * Any participant with SMA who received onasemnogene abeparvovec-xioi gene replacement therapy in a Novartis Gene Therapies-sponsored clinical study * Participant/parent/legal guardian willing and able to complete the informed consent process and comply with study procedures and visit schedule Exclusion Criteria: * Parent/legal guardian unable or unwilling to participate in the long-term follow-up safety study
Места на провеждане 9
Австралия (1)
Sydney Children's Hospital
Randwick , New South Wales
Белгия (1)
Universitair Ziekenhuis Gent
Ghent
Канада (1)
Children's Hospital of Eastern Ontario Research Institute
Ottawa , Ontario
Франция (1)
Hôpital Armand Trousseau
Paris
Италия (1)
Instituto Gianninia Gaslini
Genova
Япония (1)
Tokyo Women's Medical University Hospital
Tokyo
Taiwan (1)
National Taiwan University Hospital
Taipei
Великобритания (1)
Great Ormond Street Hospital for Children NHS Foundation Trust
London
САЩ (1)
Stanford University Medical Center
Palo Alto , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
10.02.2020
Крайна дата
31.12.2035
Регистрационен номер
NCT04042025
Източник
anzctr
Запитване за медицински туризъм

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