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临床试验/NCT05382156
NCT05382156进行中（未招募）不适用

A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome

RECORDATI GROUP43 个研究点 分布在 5 个国家目标入组 206 人开始时间: 2022年6月13日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
206
试验地点
43
主要终点
Incidence of osilodrostat-related adverse events and serious adverse events
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome

详细描述

This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.

Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis.

The total number of patients enrolled in this study will be approximately 201. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years.

研究设计

研究类型
Observational
观察模型
Other
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

  • •Written informed consent obtained prior to registration of any patient data
  • •Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.

排除标准

  • •Patients with exogenous CS
  • •Patients with Pseudo CS
  • •Patients participating in an interventional clinical trial with an investigational drug.

研究组 & 干预措施

Osilodrostat

Osilodrostat - tablets of 1mg, 5mg, 10mg - based on patients needs - up to 3 years

干预措施: Osilodrostat (Drug)

结局指标

主要结局

Incidence of osilodrostat-related adverse events and serious adverse events

时间窗: 3 years of treatment with osilodrostat

Number of participants with Adverse Events and Serious Adverse Events

次要结局

  • Change of mean urinary free cortisol (mUFC)(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change of Serum Cortisol(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change of Late Salivary Cortisol(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Normalization of adrenocorticotropic hormone (ACTH)(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Fasting Glucose(at baseline before treatment start, then every 3 months through study completion up to three years)
  • Change in Dorsal fat pad(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Changes in Patient-Reported Outcome (PRO) questionnaire Euro Quality of Life (EQ) - 5 Dimensions (5D) - 5 Levels (5L)(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Normalization of Serum Cortisol(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Hirsutism(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Change in Supraclavicular fat pad(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Change in Central (abdominal) obesity(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Short and long-term efficacy of osilodrostat(at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years)
  • Changes in pituitary tumour size(at baseline before treatment start, after 6 months of treatment, then every 12 months through study completion up to three years)
  • Change in HbA1c(at baseline before treatment start, then every 3 months through study completion up to three years)
  • Change in Serum Insulin(at baseline before treatment start, then every 3 months through study completion up to three years)
  • Incidence of Adverse Events (Safety and Tolerability)(3 years of treatment with osilodrostat)
  • Change of adrenocorticotropic hormone (ACTH)(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Normalization of Late Salivary Cortisol(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Body Mass Index (BMI)(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Striae(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Change in Ecchymoses (bruises)(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Change in Fasting Lipid Profile(at baseline before treatment start, then every 3 months through study completion up to three years)
  • Change in Blood Pressure(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Body Weight(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Waist Circumference(at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years)
  • Change in Facial Rubor(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Change in Proximal muscle wasting (atrophy)(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Changes in Patient-Reported Outcome (PRO) questionnaire Cushing Quality of Life (QoL)(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Changes in Patient-Reported Outcome (PRO) questionnaire Patient Global Impression of Change (PGIC)(after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)
  • Changes in Patient-Reported Outcome (PRO) questionnaire Beck Depression Inventory II (BDI-II)(at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (43)

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