Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
NCT ID: NCT05230550
Last Updated: 2025-04-09
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
2022-02-03
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Somapacitan
Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions
Interventions
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Somapacitan
Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions
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/LAR and the treating physician before and independently from the decision to include the patient in this study.
3. Male or female, no age limitation
4. Diagnosis of AGHD (only severe case)
5. GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.
Exclusion Criteria
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Patients with hypersensitivity to the active substance or to any of the excipients
4. Patients with malignant tumor
5. Female patients who are either pregnant or likely to be pregnant
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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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
Countries
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Other Identifiers
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U1111-1247-5417
Identifier Type: OTHER
Identifier Source: secondary_id
NN8640-4638
Identifier Type: -
Identifier Source: org_study_id
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