Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
- Conditions
- Adult Growth Hormone Deficiency
- Interventions
- Registration Number
- NCT05230550
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 200
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
- 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.
- Male or female, no age limitation
- Diagnosis of AGHD (only severe case)
- 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.
- Previous participation in this study. Participation is defined as having given informed consent in this study
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with malignant tumor
- Female patients who are either pregnant or likely to be pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with AGHD (only severe case) Somapacitan 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.
- Primary Outcome Measures
Name Time Method Number of adverse reactions From baseline (week 0) to end of study (up to 260 weeks) Measured as number
Number of serious adverse reactions From baseline (week 0) to end of study (up to 260 weeks) Measured as number
Number of adverse events From baseline (week 0) to end of study (up to 260 weeks) Measured as number
Number of serious adverse events From baseline (week 0) to end of study (up to 260 weeks) Measured as number
- Secondary Outcome Measures
Name Time Method Change in cross-sectional total adipose tissue compartments (TAT) From baseline (week 0) to end of study (up to 260 weeks) Measured as square centimeter (cm\^2)
Change in Total cholesterol (T-Cho) From baseline (week 0) to end of study (up to 260 weeks) Measured as milligrams per deciliter (mg/dL)
Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score From baseline (week 0) to end of study (up to 260 weeks) Measured as score range (1 to 5; lower score indicates a better health state)
Change in lean body mass From baseline (week 0) to end of study (up to 260 weeks) Measured as kg
Change in body fat mass From baseline (week 0) to end of study (up to 260 weeks) Measured as kilogram (kg)
Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score From baseline (week 0) to end of study (up to 260 weeks) Measured as score range (0 = unfavorable to 6 = favorable)
Change in body fat percentage From baseline (week 0) to end of study (up to 260 weeks) Measured as percent (%)
Change in subcutaneous adipose tissue compartments (SAT) From baseline (week 0) to end of study (up to 260 weeks) Measured as cm\^2
Change in visceral adipose tissue compartments (VAT) From baseline (week 0) to end of study (up to 260 weeks) Measured as cm\^2
Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) From baseline (week 0) to end of study (up to 260 weeks) Measured as standard deviation score
Change in Low Density Lipoprotein-Cholesterol (LDL-Cho) From baseline (week 0) to end of study (up to 260 weeks) Measured as mg/dL
Change in High Density Lipoprotein-Cholesterol (HDL-Cho) From baseline (week 0) to end of study (up to 260 weeks) Measured as mg/dL
Change in triglyceride From baseline (week 0) to end of study (up to 260 weeks) Measured as mg/dL
Trial Locations
- Locations (47)
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
🇯🇵Hyogo, 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
Nara Medical University Hospital_Kashihara-shi, Nara
🇯🇵Kashihara-shi, Nara, Japan
Kitasato University Hospital
🇯🇵Kanagawa, Japan
Nippon Medical School Musashikosugi Hospital_Neurological Surgery
🇯🇵Kawasaki-shi, Kanagawa, Japan
Kobe University Hospital
🇯🇵Kobe-shi, Hyogo, Japan
Kumamoto University Hospital, Diabetes, Metabo and Endo
🇯🇵Kumamoto-shi, Kumamoto, Japan
Konan Hospital
🇯🇵Kumamoto, Japan
Kyoto University Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Toranomon Hospital, Endocrinology and Metabolism
🇯🇵Minato-ku, Tokyo, Japan
Ikeda Hospital, Diabetes Medicine
🇯🇵Amagasaki-shi, Hyogo, Japan
University of Yamanashi Hospital
🇯🇵Chuo-shi, Yamanashi-ken, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka-ken, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
🇯🇵Fukuoka, Japan
Kurume University Hospital
🇯🇵Fukuoka, 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
Kibounomori Clinic
🇯🇵Oosakashi, Japan
Osaka Endocrine 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
Shizuoka General Hospital
🇯🇵Shizuoka-shi, Shizuoka-ken, Japan
Hamamatsu-kita-Hospital
🇯🇵Shizuoka, Japan
Hamamatsu Medical Center
🇯🇵Shizuoka, 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