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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 101
- 主要终点
- Number of Adverse drug reaction (ADRs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Participants with Adult Growth Hormone Deficiency (AGHD)
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 participant with Sogroya has been made prior to and independently from the decision to include the participant in this study.
干预措施: Somapacitan (Drug)
结局指标
主要结局
Number of Adverse drug reaction (ADRs)
时间窗: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as count of events.
Incident Neoplasm
时间窗: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as number of participants (yes/no).
Incident Diabetes Mellitus type 2
时间窗: From baseline (week 0) to end of study (between 1 week and a maximum of 10 years)
Measured as number of participants (yes/no).
次要结局
- Number of Medication Errors (incorrect dose administration rate)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Number of Adverse Events (AEs)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Number of Serious Adverse Events (SAEs)(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)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in lean body mass(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)(Approximately (closest routine clinical) 12 months after enrolment in study)
- Change in Weight(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in Body Mass Index (BMI)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in glycated hemoglobin (HbA1C)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in waist circumference(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in waist-hip ratio(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in truncal fat-mass(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)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Patient reaching satisfactory clinical response(Approximately (closest routine clinical) 12 months after enrolment in study)
- Change in total body fat-mass(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in bone density(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in bone mineral content(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in body fat percentage(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in visceral adipose tissue (VAT)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))
- Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)(From baseline (week 0) to end of study (between 1 week and a maximum of 10 years))