NCT07583563招募中不适用
A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Camurus AB
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.
研究概览
简要总结
The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Have started or will be starting treatment with octreotide SC depot for acromegaly
排除标准
- •Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly
- •Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.
结局指标
主要结局
Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.
时间窗: From enrollment to the end of treatment at 2 years
次要结局
- Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time.(From enrollment to the end of treatment at 2 years)
- Change in proportion of participants with IGF-1 ≤1×ULN over time.(From enrollment to the end of treatment at 2 years)
- Change in GH levels over time.(From enrollment to the end of treatment at 2 years)
- Change in proportion of participants with GH levels <1.0 μg/L over time.(From enrollment to the end of treatment at 2 years)
- Changes in symptoms of acromegaly over time, as measured by the Acromegaly Index of Severity (AIS) scale.(From enrollment to the end of treatment at 2 years)
- Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL).(From enrollment to the end of treatment at 2 years)
- Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM).(From enrollment to the end of treatment at 2 years)
- Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire.(From enrollment to the end of treatment at 2 years)
- Incidence of octreotide SC depot non-related AEs and incidence of laboratory abnormalities using the CTCAE grading scale.(From enrollment to the end of treatment at 2 years)
研究者
研究点 (7)
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