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Набор по приглашению NCT06109935

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

— Наблюдательное Growth Hormone Deficiency in Children

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Somapacitan.
Кому может быть актуально
Состояния в реестре: Growth Hormone Deficiency in Children. Базовые параметры: 0 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Япония
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed

Обзор

The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.

Вмешательства

  • Препарат Somapacitan
    Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.

Первичные конечные точки

  • Number of adverse reactions (AR) [Срок оценки: From baseline (week 0) to end of study (up to 156 weeks)]
Вторичные конечные точки (11)
  • Number of adverse events (AEs) [Срок оценки: From baseline (week 0) to end of study (up to 156 weeks)]
  • Number of serious adverse events (SAEs) [Срок оценки: From baseline (week 0) to end of study (up to 156 weeks)]
  • Number of serious adverse reactions (SARs) [Срок оценки: From baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height velocity (HV) [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in bone age [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in ratio of bone age/chronological age [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height standard deviation score (HSDS) [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in height velocity standard deviation score (HVSDS) [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Change in insulin-like growth factor-I standard deviation score (IGF-I SDS) [Срок оценки: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)]
  • Growth hormone device assessment tool (G-DAT) [Срок оценки: At 12 weeks]
  • Growth hormone patient preference questionnaire (GH-PPQ) [Срок оценки: At 12 weeks]

Критерии участия

Критерии включения

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • The decision to initiate treatment with commercially available Sogroya® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Both GH treatment naïve and non-naïve children are eligible.
  • Male or female age 0 to 18 years (exclusive) at the time of signing informed consent.
  • Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice.

Критерии исключения

  • Previous participation in this study. Participation is defined as having given informed consent in this study.
  • Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment).
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  • Contraindication described in approved product labelling in Japan.
  • Patients with hypersensitivity to the active substance or to any of the excipients
  • Patients with malignant tumour
  • Female patients who are either pregnant or likely to be pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Япония · 86 центров
  • Hoshigaoka Seicho Clinic_Pediatrics — Aichi
  • Iwayama Pediatric_Pediatrics — Aichi
  • Asai Clinic_Pediatrics — Aichi
  • Mutsu general hospital_Pediatrics — Aomori
  • Asahikawa Medical Univ. Hospital_Pediatrics — Asahikawa, Hokkaido
  • Beppu Medical Center — Beppu-shi, Oita-ken
  • Inomata Child Clinic_Pediatrics — Chiba
  • Seirei Sakura Citizen Hospital_Pediatrics — Chiba
  • … и ещё 78 центров

Идентификаторы

NCT: NCT06109935 · NN8640-5005 · U1111-1274-4223

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗