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ENROLLING BY INVITATION
NCT06109935

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Official title: A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed

Key Details

Gender

All

Age Range

0 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-10-04

Completion Date

2026-07-31

Last Updated

2025-08-29

Healthy Volunteers

No

Interventions

DRUG

Somapacitan

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

Locations (84)

Hoshigaoka Seicho Clinic_Pediatrics

Aichi, Japan

Iwayama Pediatric_Pediatrics

Aichi, Japan

Asai Clinic_Pediatrics

Aichi, Japan

Mutsu general hospital

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

Fukuoka-shi, Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Ota Memorial Hospital_Pediatrics

Gunma, Japan

Kato Clinic

Hachioji-shi, Tokyo-to, Japan

Hamamatsu University Hospital

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

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

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

Nagakute-shi, Aichi, Japan

Ina Central Hospital_Nagano

Nagano, Japan

Nagasaki University Hospital_Pediatrics

Nagasaki, Japan

Nagoya City University Hospital, Pediatric

Nagoya, Aichi, Japan

Naha City Hospital

Naha-shi, Okinawa, Japan

University of the Ryukyus Hospital

Nakagami-gun, Okinawa-ken, Japan

Nara Medical University Hospital_Pediatrics

Nara, Japan

Nara Prefecture General Medical Center

Nara-shi, Nara, Japan

Niigata University Medical & Dental Hospital_Pediatrics

Niigata-shi, Niigata, Japan

Hyogo Medical University Hospital_Pediatrics

Nishinomiya-shi, Hyogo-ken, Japan

Iwate Medical University Hospital

Numakunai, Japan

Aichi Children's Health and Medical Center

Obu-shi, Aichi, Japan

Okayama University Hospital_Pediatrics

Okayama, Japan

Asahigawasou Ryouiku Iryou Center_Pediatrics

Okayama, Japan

Chibana Clinic

Okinawa, Japan

Osaka City General Hospital_Endocrinology and Diabetes Mellitus

Osaka, Japan

Kibounomori Clinic

Osaka, Japan

JCHO Osaka Hospital_Pediatric

Osaka, Japan

Saiseikai Suita Hospital

Osaka, Japan

Osaka University Hospital

Osaka, Japan

Yasuhara Children's Clinic

Osaka, Japan

Osaka Women's and Children's Hospital

Osaka, Japan

Kojiya Kodomo clinic

Ota-ku, Tokyo-to, Japan

Okubo Kids Clinic

Ozu-shi, Ehime-ken, Japan

Clinic for Children and Youths_Pediatrics

Saitama, Japan

Sakai Smile Kids Clinic

Sashima-gun, Ibaraki-ken, Japan

JR Sendai Hospital

Sendai-shi, Miyagi-ken, Japan

Shiga university of Medical Science Hospital_Pediatrics

Shiga, Japan

Shiga General Hospital_Diabetes and Endocrinology

Shiga, Japan

My Clinic Ohkubo

Shizuoka, Japan

Shizuoka Saiseikai General Hospital_Pediatrics

Shizuoka, Japan

Hamamatsu Medical Center

Shizuoka, Japan

Iwata City Hospital_Pediatrics

Shizuoka, Japan

Shizuoka Children's Hospital, Department of Diabetes and metabolism

Shizuoka-shi, Shizuoka, Japan

Sakura Kids Clinic_Pediatrics

Tokyo, Japan

National Center for Child Health and Dev, Endo and Metabo

Tokyo, Japan

Tanaka Growth Clinic

Tokyo, Japan

Akiruno Clinic_Pediatrics

Tokyo, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Murakami Pediatric and Allergy clinic

Toyama-shi, Toyama-ken, Japan

Fujita Health University Hospital, Pediatrics

Toyoake, Aichi, Japan

Toyohashi Municipal Hospital

Toyohashi-shi, Aichi-ken, Japan

Tendo City Hospital_Pediatrics

Yamagata, Japan

Ikeda Pediatrics Clinic

Yamagata-shi, Yamagata-ken, Japan

Yamaguchi University Hospital_Pediatrics

Yamaguchi, Japan