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Само по покана Фаза 2 NCT07393373

Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Hypochondroplasia

Спонсор: QED Therapeutics, a BridgeBio company

Налично на: БГ
Обобщение
Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2/3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.
Кой може да участва
Inclusion Criteria: * Inclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Pediatric participants with HCH who have completed ACCEL 2/3 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche Exclusion Criteria: * Exclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Participant has concurrent medical condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations 2. Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication 3. Participants who prematurely discontinued ACCEL 2/3 4. Participants who have reached final height or near final height 5. Current participation in an ongoing clinical study with a sponsor other than QED
Места на провеждане 10
Австралия (1)
Murdoch Children's Research Institute
Parkville , Victoria
Канада (1)
London Health Sciences Centre - Children's Hospital of Western Ontario
London , Ontario
Франция (1)
Hôpital Femme Mère Enfant
Bron
Норвегия (1)
Haukeland University Hospital
Bergen
Португалия (1)
Hospital Pediátrico de Coimbra
Coimbra
Сингапур (1)
KK Women's and Children's Hospital
Singapore
Испания (1)
UCA Hospital MiKS
Vitoria-Gasteiz
Швеция (1)
Astrid Lindgren Children's Hospital
Solna
Великобритания (1)
The Portland Hospital for Women and Children
London , England
САЩ (1)
UCSF Benioff Children's Hospital
Oakland , California
Технически детайли
Статус
Само по покана
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
3 Years
Максимална възраст
18 Years
Здрави доброволци
Не
Начална дата
21.04.2026
Крайна дата
31.05.2036
Регистрационен номер
NCT07393373
Източник
anzctr
Запитване за медицински туризъм

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