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ENROLLING BY INVITATION
NCT05230550

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Official title: Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2022-02-03

Completion Date

2026-12-31

Last Updated

2025-04-09

Healthy Volunteers

Not specified

Interventions

DRUG

Somapacitan

Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions

Locations (47)

Ikeda Hospital, Diabetes Medicine

Amagasaki-shi, Hyogo, Japan

University of Yamanashi Hospital

Chuo-shi, Yamanashi-ken, Japan

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Fukuoka, Japan

Kurume University Hospital

Fukuoka, Japan

Fukuoka University Hospital

Fukuoka-shi, Fukuoka-ken, Japan

Kyushu University Hospital

Fukuoka-shi, Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Tsugaru General Hospital

Goshogawara-shi, Aomori-ken, Japan

Gunma University Hospital, Dept. of Endocrinology and Diabetes

Gunma, Japan

Hamamatsu University Hospital

Hamamatsu-shi, Shizuoka, Japan

Hirosaki University Hospital

Hirosaki-shi, Aomori-ken, Japan

Hyogo Prefectural Kakogawa Medical Center

Hyōgo, Japan

Takara Clinic

Iida-shi, Nagano-ken, Japan

Shimane Univ. HP, Dept of Endocrinology&Metabolism

Izumo, Shimane, Japan

Joetsu General Hospital

Joetsu-shi, Niigata-ken, Japan

Kagoshima Medical Center

Kagoshima-shi, Kagoshima-ken, Japan

Kagoshima University Hospital_Neurosurgery

Kagoshima-shi, Kagoshima, Japan

Yokohama Medical Center

Kanagawa, Japan

Kitasato University Hospital

Kanagawa, Japan

Nara Medical University Hospital_Kashihara-shi, Nara

Kashihara-shi, Nara, Japan

Nippon Medical School Musashikosugi Hospital_Neurological Surgery

Kawasaki-shi, Kanagawa, Japan

Kobe University Hospital

Kobe-shi, Hyogo, Japan

Konan Hospital

Kumamoto, Japan

Kumamoto University Hospital, Diabetes, Metabo and Endo

Kumamoto-shi, Kumamoto, Japan

Kyoto University Hospital

Kyoto-shi, Kyoto, Japan

Toranomon Hospital, Endocrinology and Metabolism

Minato-ku, Tokyo, Japan

University of Miyazaki Hospital

Miyazaki-shi, Miyazaki-ken, Japan

Aichi Medical University Hospital

Nagakute-shi, Aichi, Japan

Okamoto Internal Medicine and Pediatrics Clinic

Nara, Japan

Kurebayashi Diabetes Clinic

Nishinomiya-shi, Hyogo-ken, Japan

Okayama University Hospital_General Medicine

Okayama-shi, Okayama, Japan

Osaka Endocrine Clinic

Osaka, Japan

Kibounomori Clinic

Osaka, Japan

Osaka City University Hospital

Osaka, Japan

Yasuhara Children's Clinic

Osaka, Japan

Osaka Women's and Children's Hospital

Osaka, Japan

NTT East Japan Sapporo HP, Diabetes Mellitus & Int med Endo

Sapporo, Hokkaido, Japan

JCHO Sendai Hospital

Sendai-shi, Miyagi-ken, Japan

Omi Medical Center

Shiga, Japan

Hamamatsu-kita-Hospital

Shizuoka, Japan

Hamamatsu Medical Center

Shizuoka, Japan

Shizuoka General Hospital

Shizuoka-shi, Shizuoka-ken, Japan

Tochigi Medical Center Shimotsuga

Tochigi-shi, Tochigi-ken, Japan

Hosaka Kodomo Clinic

Tokyo, Japan

Ehime University Hospital

Toon-shi, Ehime, Japan

Tottori University Hospital_Endocrinology and Metabolism

Tottori, Japan

Yamagata University Hospital, Internal Medicine 3

Yamagata-shi, Yamagata, Japan