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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More Novo Nordisk A/S trials in Japan
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