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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1274-4223 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse reactions (AR) | Measured as count of reactions. | From baseline (week 0) to end of study (up to 156 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events (AEs) | Measured as count of events. | From baseline (week 0) to end of study (up to 156 weeks) |
| Number of serious adverse events (SAEs) | Measured as count of events. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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Children with short stature due to Growth Hormone Deficiency (GHD) where epiphysial discs are not closed under normal clinical practice conditions in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoshigaoka Seicho Clinic_Pediatrics | Aichi | 464-0801 | Japan | |||
| Iwayama Pediatric_Pediatrics |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| From baseline (week 0) to end of study (up to 156 weeks) |
| Number of serious adverse reactions (SARs) | Measured as count of reactions. | From baseline (week 0) to end of study (up to 156 weeks) |
| Change in height velocity (HV) | Measured in centimeter (cm)/year. | Every 12 months from baseline (week 0) to end of study (up to 156 weeks) |
| Change in bone age | Measured in years. | Every 12 months from baseline (week 0) to end of study (up to 156 weeks) |
| Change in ratio of bone age/chronological age | Every 12 months from baseline (week 0) to end of study (up to 156 weeks) |
| Change in height standard deviation score (HSDS) | Every 12 months from baseline (week 0) to end of study (up to 156 weeks) |
| Change in height velocity standard deviation score (HVSDS) | 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) | 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. | Every 12 months from baseline (week 0) to end of study (up to 156 weeks) |
| Growth hormone device assessment tool (G-DAT) | 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. | At 12 weeks |
| Growth hormone patient preference questionnaire (GH-PPQ) | Measured as count of patients choosing the individual response category. GH-PPQ is a disease specific questionnaire which measures the patient's growth hormone treatment preference. | At 12 weeks |
| Aichi |
| 468-0049 |
| Japan |
| Asai Clinic_Pediatrics | Aichi | 489-0883 | Japan |
| Mutsu general hospital_Pediatrics | Aomori | 035-8601 | Japan |
| Asahikawa Medical Univ. Hospital_Pediatrics | Asahikawa, Hokkaido | 078-8510 | Japan |
| Beppu Medical Center | Beppu-shi, Oita-ken | 874-0011 | Japan |
| Inomata Child Clinic_Pediatrics | Chiba | 273-0002 | Japan |
| Seirei Sakura Citizen Hospital_Pediatrics | Chiba | 285-8765 | Japan |
| Kurume University Hospital, Pediatrics | Fukuoka | 830-0011 | Japan |
| Fukuoka University Hospital | Fukuoka-shi, Fukuoka-ken | 814-0133 | Japan |
| Kyushu University Hospital_Endocrine Metab Diab inter med | Fukuoka-shi, Fukuoka | 812-8582 | Japan |
| Gifu University Hospital_The Third Dept. of Internal Medicine | Gifu | 501-1194 | Japan |
| Ota Memorial Hospital_Pediatrics | Gunma | 373-8585 | Japan |
| Kato Clinic | Hachioji-shi, Tokyo-to | 192-0919 | Japan |
| Hamamatsu University Hospital_Liver Internal Medicine | Hamamatsu-shi, Shizuoka | 431-3192 | Japan |
| Hello Clinic | Higashimatsuyama-shi, Saitama-ken | 355-0008 | Japan |
| Japanese Red Cross Society Himeji Hospital | Himeji-shi, Hyogo-ken | 670-0063 | Japan |
| Yonekura Child Clinic_Pediatrics | Hiroshima | 737-0046 | Japan |
| Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy | Hyōgo | 654-0047 | Japan |
| Nakasako Kids Clinic_Pediatrics | Hyōgo | 657-0028 | Japan |
| Nagai Kids Clinic_Pediatrics | Hyōgo | 665-0842 | Japan |
| Sunsun Kodomo Clinic | Ichikawa-shi, Chiba-ken | 272-0023 | Japan |
| Komatsu Municipal Hospital_Pediatrics | Ishikawa | 923-8560 | Japan |
| Fukushima Seishi Ryougoen | Iwaki-shi, Fukushima-ken | 970-8001 | Japan |
| Shimane University Hospital_Pediatrics | Izumo-shi, Shimane-ken | 693-0021 | Japan |
| Kagoshima University hospital_Pediatrics | Kagoshima | 890-8520 | Japan |
| University Hospital Kyoto Prefectual University of Medicine | Kamigyo-ku, Kyoto | 602-8566 | Japan |
| Muza Kawasaki Pediatric Clinic_Pediatrics | Kanagawa | 212-0014 | Japan |
| Oguchi Higashi Hospital_Pediatrics | Kanagawa | 221-0014 | Japan |
| Hanamaru Kids Clinic_Pediatrics | Kanagawa | 227-0043 | Japan |
| Odawara Municipal Hospital_Diabetes and Endocrinology | Kanagawa | 250-8558 | Japan |
| Nippon Medical School Musashikosugi Hospital_Neurological Surgery | Kawasaki-shi, Kanagawa-ken | 211-0063 | Japan |
| Hospital of the University of Occupational And Environmental Health Japan_Pediatrics | Kitakyusyu-shi, Fukuoka | 807 8555 | Japan |
| Mominoki Hospital, Pediatrics | Kochi-shi, Kochi | 780 0952 | Japan |
| Kumamoto University Hospital, Pediatrics | Kumamoto-shi, Kumamoto | 860 8556 | Japan |
| Ayabe City Hospital_Endocrinology and Diabetes | Kyoto | 623-0011 | Japan |
| University of Miyazaki Hospital_Pediatrics | Miyazaki | 889-1692 | Japan |
| Haga Red Cross Hospital | Moka-shi, Tochigi-ken | 321-4308 | Japan |
| Kodomohamirai Morioka Kodomo Clinic | Morioka-shi, Iwate-ken | 020-0102 | Japan |
| Aichi Medical University Hospital_Hepatology and pancreology | Nagakute-shi, Aichi | 480-1195 | Japan |
| Ina Central Hospital_Internal Medicine | Nagano | 396-0033 | Japan |
| Nagasaki University Hospital_Pediatrics | Nagasaki | 852-8501 | Japan |
| Nagoya City University Hospital, Pediatric | Nagoya, Aichi | 467-8602 | Japan |
| Naha City Hospital_Cardiovascular Medicine | Naha-shi, Okinawa | 902-8511 | Japan |
| University of the Ryukyus Hospital | Nakagami-gun, Okinawa-ken | 903-0125 | Japan |
| Nara Medical University Hospital_Pediatrics | Nara | 634-8522 | Japan |
| Nara Prefecture General Medical Center_Nephrology | Nara-shi, Nara | 630-8581 | Japan |
| Niigata University Medical & Dental Hospital_Pediatrics | Niigata-shi, Niigata | 951 8520 | Japan |
| Hyogo Medical University Hospital_Pediatrics | Nishinomiya-shi, Hyogo-ken | 663-8131 | Japan |
| Iwate Medical University Hospital_Diabetes and Metabolism | Numakunai | 028-3695 | Japan |
| Aichi Children's Health and Medical Center | Obu-shi, Aichi | 474-8710 | Japan |
| Okayama University Hospital_Pediatrics | Okayama | 700-8558 | Japan |
| Asahigawasou Ryouiku Iryou Center_Pediatrics | Okayama | 703-8555 | Japan |
| Chibana Clinic | Okinawa | 904-2143 | Japan |
| Osaka City General Hospital | Osaka | 534-0021 | Japan |
| Kibounomori Clinic | Osaka | 540-0003 | Japan |
| JCHO Osaka Hospital_Pediatric | Osaka | 553-0003 | Japan |
| Saiseikai Suita Hospital_Metabolism and Diabetes Intern | Osaka | 564-0013 | Japan |
| The University of Osaka Hospital_Metabolic Medicine | Osaka | 565-0871 | Japan |
| Yasuhara Children's Clinic | Osaka | 572-0085 | Japan |
| Osaka Women's and Children's Hospital | Osaka | 594-1101 | Japan |
| Kojiya Kodomo clinic | Ota-ku, Tokyo-to | 144-0034 | Japan |
| Okubo Kids Clinic | Ozu-shi, Ehime-ken | 795-0061 | Japan |
| Clinic for Children and Youths_Pediatrics | Saitama | 336-0967 | Japan |
| Sakai Smile Kids Clinic | Sashima-gun, Ibaraki-ken | 306-0434 | Japan |
| JR Sendai Hospital | Sendai-shi, Miyagi-ken | 980-0022 | Japan |
| Shiga university of Medical Science Hospital_Pediatrics | Shiga | 520-2192 | Japan |
| Shiga General Hospital_Diabetes and Endocrinology | Shiga | 524-0022 | Japan |
| My Clinic Ohkubo | Shizuoka | 420-0923 | Japan |
| Shizuoka Saiseikai General Hospital_Pediatrics | Shizuoka | 422-8527 | Japan |
| Hamamatsu Medical Center_Endocrinology and Metabolism | Shizuoka | 432-8580 | Japan |
| Iwata City Hospital_Pediatrics | Shizuoka | 438-8550 | Japan |
| Shizuoka Children's Hospital, Department of Diabetes and metabolism | Shizuoka-shi, Shizuoka | 420-8660 | Japan |
| Tokushima University Hospital_Pediatrics | Tokushima | 770-8503 | Japan |
| Sakura Kids Clinic_Pediatrics | Tokyo | 154-0015 | Japan |
| National Center for Child Health and Development_Endo and Metabo | Tokyo | 157 8535 | Japan |
| Tanaka Growth Clinic | Tokyo | 158-0097 | Japan |
| Kyorin University Hospital_Pediatrics | Tokyo | 181-0004 | Japan |
| Akiruno Clinic_Pediatrics | Tokyo | 197-0802 | Japan |
| Ehime University Hospital_Department of Gastro.& Metabo. | Toon-shi, Ehime | 791-0295 | Japan |
| Murakami Pediatric and Allergy clinic | Toyama-shi, Toyama-ken | 930-0827 | Japan |
| Fujita Health University Hospital, Pediatrics | Toyoake, Aichi | 470-1192 | Japan |
| Toyohashi Municipal Hospital | Toyohashi-shi, Aichi-ken | 441-8085 | Japan |
| Tendo City Hospital_Pediatrics | Yamagata | 994-0047 | Japan |
| Ikeda Pediatrics Clinic | Yamagata-shi, Yamagata-ken | 990-2313 | Japan |
| Yamaguchi University Hospital_Pediatrics | Yamaguchi | 755-8505 | Japan |
| ID | Term |
|---|---|
| C000718308 | somapacitan |
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