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
NCT ID: NCT06109935
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
200 participants
OBSERVATIONAL
2023-10-04
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Somapacitan
Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.
Interventions
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Somapacitan
Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
0 Years
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency dept. 2834
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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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
Countries
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Other Identifiers
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U1111-1274-4223
Identifier Type: OTHER
Identifier Source: secondary_id
NN8640-5005
Identifier Type: -
Identifier Source: org_study_id
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