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Enrolling by invitation Observational

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

NCT06109935 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2023-10-04
Last updated
2026-04-29

Condition(s) studied

Growth Hormone Deficiency in Children

Investigational drug(s) / intervention(s)

Somapacitan →

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

Study summary

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.

Eligibility

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. 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. 3. Male or female age 0 to 18 years (exclusive) at the time of signing informed consent. 4. Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice. Exclusion Criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment). 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. Contraindication described in approved product labelling in Japan. 1. Patients with hypersensitivity to the active substance or to any of the excipients 2. Patients with malignant tumour 3. Female patients who are either pregnant or likely to be pregnant

Primary outcome measure(s)

  • Number of adverse reactions (AR) — From baseline (week 0) to end of study (up to 156 weeks)
    Measured as count of reactions.

Trial sites (86)

FacilityCityRegionStatus
Hoshigaoka Seicho Clinic_Pediatrics Aichi Japan
Iwayama Pediatric_Pediatrics Aichi Japan
Asai Clinic_Pediatrics Aichi Japan
Mutsu general hospital_Pediatrics Aomori Japan
Asahikawa Medical Univ. Hospital_Pediatrics Asahikawa, Hokkaido Japan
Beppu Medical Center Beppu-shi, Oita-ken Japan
Inomata Child Clinic_Pediatrics Chiba Japan
Seirei Sakura Citizen Hospital_Pediatrics Chiba Japan
Kurume University Hospital, Pediatrics Fukuoka Japan
Fukuoka University Hospital Fukuoka-shi, Fukuoka-ken Japan
Kyushu University Hospital_Endocrine Metab Diab inter med Fukuoka-shi, Fukuoka Japan
Gifu University Hospital_The Third Dept. of Internal Medicine Gifu Japan
Ota Memorial Hospital_Pediatrics Gunma Japan
Kato Clinic Hachioji-shi, Tokyo-to Japan
Hamamatsu University Hospital_Liver Internal Medicine Hamamatsu-shi, Shizuoka Japan
Hello Clinic Higashimatsuyama-shi, Saitama-ken Japan
Japanese Red Cross Society Himeji Hospital Himeji-shi, Hyogo-ken Japan
Yonekura Child Clinic_Pediatrics Hiroshima Japan
Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy Hyōgo Japan
Nakasako Kids Clinic_Pediatrics Hyōgo Japan
Nagai Kids Clinic_Pediatrics Hyōgo Japan
Sunsun Kodomo Clinic Ichikawa-shi, Chiba-ken Japan
Komatsu Municipal Hospital_Pediatrics Ishikawa Japan
Fukushima Seishi Ryougoen Iwaki-shi, Fukushima-ken Japan
Shimane University Hospital_Pediatrics Izumo-shi, Shimane-ken Japan
Kagoshima University hospital_Pediatrics Kagoshima Japan
University Hospital Kyoto Prefectual University of Medicine Kamigyo-ku, Kyoto Japan
Muza Kawasaki Pediatric Clinic_Pediatrics Kanagawa Japan
Oguchi Higashi Hospital_Pediatrics Kanagawa Japan
Hanamaru Kids Clinic_Pediatrics Kanagawa Japan
Odawara Municipal Hospital_Diabetes and Endocrinology Kanagawa Japan
Nippon Medical School Musashikosugi Hospital_Neurological Surgery Kawasaki-shi, Kanagawa-ken Japan
Hospital of the University of Occupational And Environmental Health Japan_Pediatrics Kitakyusyu-shi, Fukuoka Japan
Mominoki Hospital, Pediatrics Kochi-shi, Kochi Japan
Kumamoto University Hospital, Pediatrics Kumamoto-shi, Kumamoto Japan
Ayabe City Hospital_Endocrinology and Diabetes Kyoto Japan
University of Miyazaki Hospital_Pediatrics Miyazaki Japan
Haga Red Cross Hospital Moka-shi, Tochigi-ken Japan
Kodomohamirai Morioka Kodomo Clinic Morioka-shi, Iwate-ken Japan
Aichi Medical University Hospital_Hepatology and pancreology Nagakute-shi, Aichi Japan

+ 46 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06109935 on ClinicalTrials.gov ↗ ← All trials in Japan