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

Enrolling by invitation

Conditions studied: Growth Hormone Deficiency in Children

In brief

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.

Key facts

Study ID

NCT06109935

Run by

Novo Nordisk A/S

People needed

200

Starts

2023-10-04

Expected to finish

2026-12-31

Last updated by the study team

2026-04-29

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Hoshigaoka Seicho Clinic_Pediatrics — Aichi, Japan

Full record on ClinicalTrials.gov

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