A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Официальное название

A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

Обзор

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Вмешательства

• Препарат Somapacitan
  Sogroya therapy in participants with AGHD.

Первичные конечные точки

• Number of Adverse drug reaction (ADRs) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Incident Neoplasm [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Incident Diabetes Mellitus type 2 [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]

Вторичные конечные точки (12)

• Number of Adverse Events (AEs) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Number of Serious Adverse Events (SAEs) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Number of Medication Errors (incorrect dose administration rate) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2) [Срок оценки: Approximately (closest routine clinical) 12 months after enrolment in study]
• Change in Weight [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in Body Mass Index (BMI) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in waist circumference [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in waist-hip ratio [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in glycated hemoglobin (HbA1C) [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]
• Change in bone density [Срок оценки: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)]

Критерии участия

Критерии включения

• 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 (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
• Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent.
• Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.

Критерии исключения

• Previous participation in this study. Participation is defined as signed informed consent.
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• Participant with hypersensitivity to the active substance or to any of the excipients.
• Participant with active malignancy or in treatment for active pre-existing malignancy.
• Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 29 центров

• Barrow Neurological Institute — Phoenix
• Keck Medical Center of USC - Outpatient Clinic — Los Angeles
• UCLA Health — Los Angeles
• Stanford Univ School of Med — Palo Alto
• Advanced Rx Clinical Research — Westminster
• Anschutz Outpatient Pavilion — Aurora
• Metabolic Research Institute Inc — West Palm Beach
• Atlanta Diabetes Associates — Atlanta
• … и ещё 21 центр

Германия · 10 центров

• Uniklinik Aachen - Endokrinologie und Diabetologie — Aachen
• Endokrinologikum Frankfurt — Frankfurt am Main
• Universitätsklinikum Halle - Innere Medizin III — Halle
• Universitätsmedizin der JGU Mainz - Endokrinologie und Stoffwechselerkrankungen — Mainz
• LMU Klinikum Großhadern München - Med. Klinik — München
• Medicover Neuroendokrinologie MVZ München — München
• Medicover Neuroendokrinologie MVZ — München
• Medicover MVZ Oldenburg — Oldenburg
• … и ещё 2 центра

Япония · 6 центров

• Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus — Chikushino-shi, Fukuoka
• Kagoshima University Hospital_Neurosurgery — Kagoshima-shi, Kagoshima
• Nippon Medical School Musashikosugi Hospital_Neurological Surgery — Kawasaki-shi, Kanagawa
• Kobe University Hospital_Diabetes and Endocrinology — Kobe-shi, Hyogo
• Okayama University Hospital_General Medicine — Okayama-shi, Okayama
• Osaka City General Hospital_Endocrinology and Diabetes Mellitus — Osaka-shi, Osaka

Франция · 5 центров

• HCL - HOPITAL LOUIS PRADEL - Service d'endocrinologie — Bron
• CHU LILLE - HOPITAL CLAUDE HURIEZ - Service d'endocrinologie et diabétologie — Lille
• APHM - HOPITAL DE LA CONCEPTION - Service d'endocrinologie, nutrition, diabète et obésité — Marseille
• APHP - LA PITIE SALPETRIERE_Service endrocrinologie et medecine de la reproduction — Paris
• CHU REIMS - HOPITAL ROBERT DEBRE - Service Endocrinologie-Diabète-Nutrition — Reims

Саудовская Аравия · 4 центра

• Dr Soliman Fakeeh Hospital — Jeddah
• My clinic — Jeddah
• Dr. Sulaiman Al Habib Medical Group- Olaya — Riyadh
• King Fahad Medical City — Riyadh

Словения · 1 центр

• UKC Ljubljana, Endocrinology and Diabetes — Ljubljana

Идентификаторы

NCT: NCT05718570 · NN8640-4515 · U1111-1264-8642

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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