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Активно (без набиране) Фаза 3 NCT06079372

Phase 3 Study of ALXN1850 in Pediatric Participants With HPP Previously Treated With Asfotase Alfa

Фаза 3 – широко изпитване преди одобрение
Заболявания: Hypophosphatasia

Спонсор: Alexion Pharmaceuticals, Inc.

Налично на: БГ
Обобщение
The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.
Кой може да участва
Inclusion Criteria: * Diagnosis of HPP documented in the medical records * Presence of open growth plates by X-ray during Screening Period * Tanner stage 2 or less during the Screening Period * Must have been treated with 6 mg/kg/ week of asfotase alfa via SC injection administered as either 2mg/kg 3 times per week or 1 mg/kg 6 times per week for ≥ 6 months before Day 1. Note: participants currently treated with 9 mg/kg (eg, 3 mg/kg 3 times per week) will not be allowed in the study. Exclusion Criteria: * History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological disorders, or any other disorders that are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data as determined by the Investigator. * Diagnosis of primary or secondary hyperparathyroidism * Hypoparathyroidism, unless secondary to HPP * Any new fracture within 12 weeks before Day 1 (excluding pseudofractures) * Planned surgical intervention which may impact the results of study assessments (in the opinion of the Investigator) during the Randomized Evaluation Period * History of allergy or hypersensitivity to any ingredient contained in asfotase alfa or ALXN1850 * Body weight \< 10 kg during the Screening Period
Места на провеждане 7
Argentina (1)
Research Site
Mar del Plata
Австралия (1)
Research Site
South Brisbane
Канада (1)
Research Site
Ottawa , Ontario
Япония (1)
Research Site
Bunkyō City
Турция (1)
Research Site
Altındağ
Великобритания (1)
Research Site
Birmingham
САЩ (1)
Research Site
Hartford , Connecticut
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
11 Years
Здрави доброволци
Не
Начална дата
02.04.2024
Крайна дата
29.02.2028
Регистрационен номер
NCT06079372
Източник
anzctr
Запитване за медицински туризъм

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