DRUG
Somapacitan
Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.
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
Status
Enrolling by invitation
Phase
Not applicable
Enrollment
200
Locations
86
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 31, 2023
Study start
Oct 4, 2023
Primary completion
Jul 31, 2026
Study completion
Dec 31, 2026
Results posted
Not reported
Registry updated
Apr 29, 2026
Outcomes
What the study measures.
Primary outcomes
Number of adverse reactions (AR)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Measured as count of reactions.
Secondary outcomes
Number of adverse events (AEs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Measured as count of events.
Number of serious adverse events (SAEs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Measured as count of events.
Number of serious adverse reactions (SARs)
Time frame · From baseline (week 0) to end of study (up to 156 weeks)
Measured as count of reactions.
Change in height velocity (HV)
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Measured in centimeter (cm)/year.
Change in bone age
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Measured in years.
Change in ratio of bone age/chronological age
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Change in height standard deviation score (HSDS)
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Change in height velocity standard deviation score (HVSDS)
Time frame · 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)
Time frame · Every 12 months from baseline (week 0) to end of study (up to 156 weeks)
Measured as score ranging from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome.
Growth hormone device assessment tool (G-DAT)
Time frame · At 12 weeks
Measured as count of patients choosing the individual response category. G-DAT is a questionnaire to gather information on how they feel about the GH product device assessed as "very easy", "easy", "neither difficult or easy", "difficult" or "very difficult" where "very easy" is best and "very difficult" is worst.
Eligibility
Who can take part.
- Minimum age
- 0 Years
- Maximum age
- 18 Years
- Sex
- ALL
- 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
Study locations
86 registered sites.
Japan. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.