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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-5417 | Other Identifier | World Health Organization (WHO) |
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Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with AGHD (only severe case) | Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. The decision to treat a patient with Sogroya® has been made at the treating physician's discretion and independently from the decision to include the patient in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Measured as number | From baseline (week 0) to end of study (up to 260 weeks) |
| Number of serious adverse events | Measured as number | From baseline (week 0) to end of study (up to 260 weeks) |
| Number of serious adverse reactions | Measured as number | From baseline (week 0) to end of study (up to 260 weeks) |
| Number of adverse reactions | Measured as number | From baseline (week 0) to end of study (up to 260 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body fat mass | Measured as kilogram (kg) | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in body fat percentage | Measured as percent (%) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Adult Growth Hormone Deficiency (only severe case)
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ikeda Hospital_Diabetes Medicine | Amagasaki-shi, Hyogo | 661-0002 | Japan | |||
| University of Yamanashi Hospital |
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 260 weeks) |
| Change in lean body mass | Measured as kg | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in cross-sectional total adipose tissue compartments (TAT) | Measured as square centimeter (cm^2) | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in subcutaneous adipose tissue compartments (SAT) | Measured as cm^2 | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in visceral adipose tissue compartments (VAT) | Measured as cm^2 | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in Total cholesterol (T-Cho) | Measured as milligrams per deciliter (mg/dL) | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in Low Density Lipoprotein-Cholesterol (LDL-Cho) | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in High Density Lipoprotein-Cholesterol (HDL-Cho) | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in triglyceride | Measured as mg/dL | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) | Measured as standard deviation score | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score | Measured as score range (0 = unfavorable to 6 = favorable) | From baseline (week 0) to end of study (up to 260 weeks) |
| Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score | Measured as score range (1 to 5; lower score indicates a better health state) | From baseline (week 0) to end of study (up to 260 weeks) |
| Chuo-shi, Yamanashi-ken |
| 409-3821 |
| Japan |
| Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus | Fukuoka | 818 8502 | Japan |
| Kurume University Hospital | 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 |
| Tsugaru General Hospital_Endocrinology and Diabetes | Goshogawara-shi, Aomori-ken | 037-0074 | Japan |
| Gunma University Hospital_Endocrinology and Diabetes | Gunma | 371-8511 | Japan |
| Hamamatsu University Hospital_Liver Internal Medicine | Hamamatsu-shi, Shizuoka | 431-3192 | Japan |
| Hirosaki University Hospital | Hirosaki-shi, Aomori-ken | 036-8203 | Japan |
| Hyogo Prefectural Kakogawa Medical Center_Diabetes and Endocrinology | Hyōgo | 675-8555 | Japan |
| Takara Clinic | Iida-shi, Nagano-ken | 395-0804 | Japan |
| Shimane Univ. HP, Dept of Endocrinology&Metabolism | Izumo, Shimane | 691-8501 | Japan |
| Joetsu General Hospital | Joetsu-shi, Niigata-ken | 943-0172 | Japan |
| Kagoshima Medical Center | Kagoshima-shi, Kagoshima-ken | 892-0853 | Japan |
| Kagoshima University Hospital_Neurosurgery | Kagoshima-shi, Kagoshima | 890-8520 | Japan |
| Yokohama Medical Center_Diabetes and Endocrinology | Kanagawa | 245-8575 | Japan |
| Kitasato University Hospital_Blood Transfusion | Kanagawa | 252-0375 | Japan |
| Nara Medical University Hospital_Department of Gastro.& Metabo. | Kashihara-shi, Nara | 634-8522 | Japan |
| Nippon Medical School Musashikosugi Hospital_Neurological Surgery | Kawasaki-shi, Kanagawa | 211-8533 | Japan |
| Kobe University Hospital_Radiology | Kobe-shi, Hyogo | 650-0017 | Japan |
| Konan Hospital | Kumamoto | 862-0970 | Japan |
| Kumamoto University Hospital, Diabetes, Metabo and Endo | Kumamoto-shi, Kumamoto | 860-0811 | Japan |
| Kyoto University Hospital_Department of Diabetes, Endocr | Kyoto-shi, Kyoto | 606-8507 | Japan |
| Toranomon Hospital, Endocrinology and Metabolism | Minato-ku, Tokyo | 105-8470 | Japan |
| University of Miyazaki Hospital | Miyazaki-shi, Miyazaki-ken | 889-1601 | Japan |
| Aichi Medical University Hospital_Hepatology and pancreology | Nagakute-shi, Aichi | 480-1195 | Japan |
| Okamoto Internal Medicine and Pediatrics Clinic | Nara | 633-0064 | Japan |
| Kurebayashi Diabetes Clinic | Nishinomiya-shi, Hyogo-ken | 663-8024 | Japan |
| Okayama University Hospital_General Medicine | Okayama-shi, Okayama | 700-8558 | Japan |
| Osaka Endocrine Clinic | Osaka | 530-0013 | Japan |
| Kibounomori Clinic | Osaka | 540-0003 | Japan |
| Osaka City University Hospital_Metabolism and Endocrinology | Osaka | 545-8586 | Japan |
| Yasuhara Children's Clinic | Osaka | 572-0085 | Japan |
| Osaka Women's and Children's Hospital | Osaka | 594-1101 | Japan |
| NTT East Japan Sapporo HP_Diabetes Mellitus & Int med Endo | Sapporo, Hokkaido | 060-8648 | Japan |
| JCHO Sendai Hospital | Sendai-shi, Miyagi-ken | 981-3205 | Japan |
| Omi Medical Center_Cardiovascular Medicine | Shiga | 525-8585 | Japan |
| Hamamatsu-kita-Hospital_Internal Medicine | Shizuoka | 431-3113 | Japan |
| Hamamatsu Medical Center_Endocrinology and Metabolism | Shizuoka | 432-8580 | Japan |
| Shizuoka General Hospital | Shizuoka-shi, Shizuoka-ken | 420-0881 | Japan |
| Tochigi Medical Center Shimotsuga_Neurosurgery | Tochigi-shi, Tochigi-ken | 329-4407 | Japan |
| Hosaka Kodomo Clinic | Tokyo | 112-0001 | Japan |
| Ehime University Hospital_Department of Gastro.& Metabo. | Toon-shi, Ehime | 791-0295 | Japan |
| Tottori University Hospital_Endocrinology and Metabolism | Tottori | 683-8504 | Japan |
| Yamagata University Hospital, Internal Medicine 3 | Yamagata-shi, Yamagata | 990-9585 | Japan |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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