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An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly

2026年8月11日 更新者：Camurus AB

A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 德国
      • Aachen、德国、52074
        • 尚未招聘
        • Universitaetsklinikum Aachen
      • Leipzig、德国、04103
        • 招聘中
        • Universitaetsklinikum Leipzig
      • Magdeburg、德国、39110
        • 招聘中
        • Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie
      • München、德国、81667
        • 尚未招聘
        • Medicover Neuroendokrinologie MVZ
      • Würzburg、德国、97080
        • 招聘中
        • Universitätsklinikum Würzburg
  • 英国
      • Leeds、英国、LS9 7TF
        • 尚未招聘
        • St James's University Hospital - Leeds Teaching Hospitals NHS Trust

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study will enroll patients with acromegaly who are considered for treatment with octreotide subcutaneous depot and patients with acromegaly who have already initiated octreotide subcutaneous depot treatment. The study will be conducted in Germany, the UK, and the US.

描述

Inclusion Criteria:

  • Have started or will be starting treatment with octreotide SC depot for acromegaly

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.
大体时间：From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years

次要结果测量

结果测量
措施说明
大体时间
Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time.
大体时间：From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
Change in proportion of participants with IGF-1 ≤1×ULN over time.
大体时间：From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
Change in GH levels over time.
大体时间：From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years
Change in proportion of participants with GH levels <1.0 μg/L over time.
大体时间：From enrollment to the end of treatment at 2 years
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.
大体时间：From enrollment to the end of treatment at 2 years
The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms.
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).
大体时间：From enrollment to the end of treatment at 2 years
The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life.
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).
大体时间：From enrollment to the end of treatment at 2 years
The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction.
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.
大体时间：From enrollment to the end of treatment at 2 years
The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms.
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.
大体时间：From enrollment to the end of treatment at 2 years
From enrollment to the end of treatment at 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Camurus AB

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月5日

初级完成 (估计的)

2029年6月1日

研究完成 (估计的)

2029年6月1日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年5月8日

首次发布 (实际的)

2026年5月13日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HS-24-799

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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