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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 79
- 主要终点
- Number of serious adverse reactions
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 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® 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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Somapacitan (Drug)
结局指标
主要结局
Number of serious adverse reactions
时间窗: From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of adverse events
时间窗: From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of serious adverse events
时间窗: From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
Number of adverse reactions
时间窗: From baseline (week 0) to end of study (up to 260 weeks)
Measured as number
次要结局
- Change in cross-sectional total adipose tissue compartments (TAT)(From baseline (week 0) to end of study (up to 260 weeks))
- Change in Total cholesterol (T-Cho)(From baseline (week 0) to end of study (up to 260 weeks))
- 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))
- Change in lean body mass(From baseline (week 0) to end of study (up to 260 weeks))
- Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score(From baseline (week 0) to end of study (up to 260 weeks))
- Change in body fat mass(From baseline (week 0) to end of study (up to 260 weeks))
- Change in body fat percentage(From baseline (week 0) to end of study (up to 260 weeks))
- Change in subcutaneous adipose tissue compartments (SAT)(From baseline (week 0) to end of study (up to 260 weeks))
- Change in visceral adipose tissue compartments (VAT)(From baseline (week 0) to end of study (up to 260 weeks))
- 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))
- Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)(From baseline (week 0) to end of study (up to 260 weeks))
- Change in High Density Lipoprotein-Cholesterol (HDL-Cho)(From baseline (week 0) to end of study (up to 260 weeks))
- Change in triglyceride(From baseline (week 0) to end of study (up to 260 weeks))