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 | Enrolling By Invitation

• 2 other identifiers: NN8640-5005U1111-1274-4223
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 86

Brief 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.

Conditions

Growth Hormone Deficiency in Children

Outcome Measures

Primary Outcomes (1)

• Number of adverse reactions (AR)

  Measured as count of reactions.

  From baseline (week 0) to end of study (up to 156 weeks)

Secondary Outcomes (11)

• Number of adverse events (AEs)

  From baseline (week 0) to end of study (up to 156 weeks)

• Number of serious adverse events (SAEs)

  From baseline (week 0) to end of study (up to 156 weeks)

• Number of serious adverse reactions (SARs)

  From baseline (week 0) to end of study (up to 156 weeks)

• Change in height velocity (HV)

  Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

• Change in bone age

  Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

Study Arms (1)

Children with GHD

Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Sogroya® is made at the treating physician's discretion before and independently from the decision to include the patient in this study.

Drug: Somapacitan

Interventions

Somapacitan DRUG

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

Also known as: Sogroya®

Children with GHD

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with short stature due to Growth Hormone Deficiency (GHD) where epiphysial discs are not closed under normal clinical practice conditions in Japan.

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (86)

Hoshigaoka Seicho Clinic_Pediatrics

Aichi, 464-0801, Japan

Location

Iwayama Pediatric_Pediatrics

Aichi, 468-0049, Japan

Location

Asai Clinic_Pediatrics

Aichi, 489-0883, Japan

Location

Mutsu general hospital_Pediatrics

Aomori, 035-8601, Japan

Location

Asahikawa Medical Univ. Hospital_Pediatrics

Asahikawa, Hokkaido, 078-8510, Japan

Location

Beppu Medical Center

Beppu-shi, Oita-ken, 874-0011, Japan

Location

Inomata Child Clinic_Pediatrics

Chiba, 273-0002, Japan

Location

Seirei Sakura Citizen Hospital_Pediatrics

Chiba, 285-8765, Japan

Location

Kurume University Hospital, Pediatrics

Fukuoka, 830-0011, Japan

Location

Fukuoka University Hospital

Fukuoka-shi, Fukuoka-ken, 814-0133, Japan

Location

Kyushu University Hospital_Endocrine Metab Diab inter med

Fukuoka-shi, Fukuoka, 812-8582, Japan

Location

Gifu University Hospital_The Third Dept. of Internal Medicine

Gifu, 501-1194, Japan

Location

Ota Memorial Hospital_Pediatrics

Gunma, 373-8585, Japan

Location

Kato Clinic

Hachioji-shi, Tokyo-to, 192-0919, Japan

Location

Hamamatsu University Hospital_Liver Internal Medicine

Hamamatsu-shi, Shizuoka, 431-3192, Japan

Location

Hello Clinic

Higashimatsuyama-shi, Saitama-ken, 355-0008, Japan

Location

Japanese Red Cross Society Himeji Hospital

Himeji-shi, Hyogo-ken, 670-0063, Japan

Location

Yonekura Child Clinic_Pediatrics

Hiroshima, 737-0046, Japan

Location

Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy

Hyōgo, 654-0047, Japan

Location

Nakasako Kids Clinic_Pediatrics

Hyōgo, 657-0028, Japan

Location

Nagai Kids Clinic_Pediatrics

Hyōgo, 665-0842, Japan

Location

Sunsun Kodomo Clinic

Ichikawa-shi, Chiba-ken, 272-0023, Japan

Location

Komatsu Municipal Hospital_Pediatrics

Ishikawa, 923-8560, Japan

Location

Fukushima Seishi Ryougoen

Iwaki-shi, Fukushima-ken, 970-8001, Japan

Location

Shimane University Hospital_Pediatrics

Izumo-shi, Shimane-ken, 693-0021, Japan

Location

Kagoshima University hospital_Pediatrics

Kagoshima, 890-8520, Japan

Location

University Hospital Kyoto Prefectual University of Medicine

Kamigyo-ku, Kyoto, 602-8566, Japan

Location

Muza Kawasaki Pediatric Clinic_Pediatrics

Kanagawa, 212-0014, Japan

Location

Oguchi Higashi Hospital_Pediatrics

Kanagawa, 221-0014, Japan

Location

Hanamaru Kids Clinic_Pediatrics

Kanagawa, 227-0043, Japan

Location

Odawara Municipal Hospital_Diabetes and Endocrinology

Kanagawa, 250-8558, Japan

Location

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa-ken, 211-0063, Japan

Location

Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

Kitakyusyu-shi, Fukuoka, 807 8555, Japan

Location

Mominoki Hospital, Pediatrics

Kochi-shi, Kochi, 780 0952, Japan

Location

Kumamoto University Hospital, Pediatrics

Kumamoto-shi, Kumamoto, 860 8556, Japan

Location

Ayabe City Hospital_Endocrinology and Diabetes

Kyoto, 623-0011, Japan

Location

University of Miyazaki Hospital_Pediatrics

Miyazaki, 889-1692, Japan

Location

Haga Red Cross Hospital

Moka-shi, Tochigi-ken, 321-4308, Japan

Location

Kodomohamirai Morioka Kodomo Clinic

Morioka-shi, Iwate-ken, 020-0102, Japan

Location

Aichi Medical University Hospital_Hepatology and pancreology

Nagakute-shi, Aichi, 480-1195, Japan

Location

Ina Central Hospital_Internal Medicine

Nagano, 396-0033, Japan

Location

Nagasaki University Hospital_Pediatrics

Nagasaki, 852-8501, Japan

Location

Nagoya City University Hospital, Pediatric

Nagoya, Aichi, 467-8602, Japan

Location

Naha City Hospital_Cardiovascular Medicine

Naha-shi, Okinawa, 902-8511, Japan

Location

University of the Ryukyus Hospital

Nakagami-gun, Okinawa-ken, 903-0125, Japan

Location

Nara Medical University Hospital_Pediatrics

Nara, 634-8522, Japan

Location

Nara Prefecture General Medical Center_Nephrology

Nara-shi, Nara, 630-8581, Japan

Location

Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, 951 8520, Japan

Location

Hyogo Medical University Hospital_Pediatrics

Nishinomiya-shi, Hyogo-ken, 663-8131, Japan

Location

Iwate Medical University Hospital_Diabetes and Metabolism

Numakunai, 028-3695, Japan

Location

Aichi Children's Health and Medical Center

Obu-shi, Aichi, 474-8710, Japan

Location

Okayama University Hospital_Pediatrics

Okayama, 700-8558, Japan

Location

Asahigawasou Ryouiku Iryou Center_Pediatrics

Okayama, 703-8555, Japan

Location

Chibana Clinic

Okinawa, 904-2143, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Kibounomori Clinic

Osaka, 540-0003, Japan

Location

JCHO Osaka Hospital_Pediatric

Osaka, 553-0003, Japan

Location

Saiseikai Suita Hospital_Metabolism and Diabetes Intern

Osaka, 564-0013, Japan

Location

The University of Osaka Hospital_Metabolic Medicine

Osaka, 565-0871, Japan

Location

Yasuhara Children's Clinic

Osaka, 572-0085, Japan

Location

Osaka Women's and Children's Hospital

Osaka, 594-1101, Japan

Location

Kojiya Kodomo clinic

Ota-ku, Tokyo-to, 144-0034, Japan

Location

Okubo Kids Clinic

Ozu-shi, Ehime-ken, 795-0061, Japan

Location

Clinic for Children and Youths_Pediatrics

Saitama, 336-0967, Japan

Location

Sakai Smile Kids Clinic

Sashima-gun, Ibaraki-ken, 306-0434, Japan

Location

JR Sendai Hospital

Sendai-shi, Miyagi-ken, 980-0022, Japan

Location

Shiga university of Medical Science Hospital_Pediatrics

Shiga, 520-2192, Japan

Location

Shiga General Hospital_Diabetes and Endocrinology

Shiga, 524-0022, Japan

Location

My Clinic Ohkubo

Shizuoka, 420-0923, Japan

Location

Shizuoka Saiseikai General Hospital_Pediatrics

Shizuoka, 422-8527, Japan

Location

Hamamatsu Medical Center_Endocrinology and Metabolism

Shizuoka, 432-8580, Japan

Location

Iwata City Hospital_Pediatrics

Shizuoka, 438-8550, Japan

Location

Shizuoka Children's Hospital, Department of Diabetes and metabolism

Shizuoka-shi, Shizuoka, 420-8660, Japan

Location

Tokushima University Hospital_Pediatrics

Tokushima, 770-8503, Japan

Location

Sakura Kids Clinic_Pediatrics

Tokyo, 154-0015, Japan

Location

National Center for Child Health and Development_Endo and Metabo

Tokyo, 157 8535, Japan

Location

Tanaka Growth Clinic

Tokyo, 158-0097, Japan

Location

Kyorin University Hospital_Pediatrics

Tokyo, 181-0004, Japan

Location

Akiruno Clinic_Pediatrics

Tokyo, 197-0802, Japan

Location

Ehime University Hospital_Department of Gastro.& Metabo.

Toon-shi, Ehime, 791-0295, Japan

Location

Murakami Pediatric and Allergy clinic

Toyama-shi, Toyama-ken, 930-0827, Japan

Location

Fujita Health University Hospital, Pediatrics

Toyoake, Aichi, 470-1192, Japan

Location

Toyohashi Municipal Hospital

Toyohashi-shi, Aichi-ken, 441-8085, Japan

Location

Tendo City Hospital_Pediatrics

Yamagata, 994-0047, Japan

Location

Ikeda Pediatrics Clinic

Yamagata-shi, Yamagata-ken, 990-2313, Japan

Location

Yamaguchi University Hospital_Pediatrics

Yamaguchi, 755-8505, Japan

Location

MeSH Terms

Interventions

somapacitan

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: October 4, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (86)