NCT04872920Unknown不适用
Prospective, Multi-country, Observational Registry to Collect Clinical Information on Patients With Endogenous Cushing's Syndrome to Assess Drug Utilization Pattern and to Document the Safety and Effectiveness of Ketoconazole.
HRA Pharma6 个研究点 分布在 4 个国家目标入组 200 人开始时间: 2018年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole.
研究概览
简要总结
This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.
详细描述
The aim is to further document the safety and efficacy of Ketoconazole HRA administered in routine clinical practice in patients with CS.
The study operates under real clinical practice conditions, i.e. there is no treatment protocol thus.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged from 12 years or older with a diagnosis of CS
- •Patients who started ketoconazole therapy after study start
- •For patients previously treated with ketoconazole, patients must have taken their last dose at least 6 months before starting ketoconazole again in this study.
- •Written informed consent signed prior to registration of any patient data in HRA modules.
排除标准
- •Adrenal cortical carcinoma
- •Patients currently participating in any other trial (interventional or not) of an investigational medicine or participation in the past one month before start of ketoconazole
- •Patients who have at least one contraindication among those listed in section 4.3 of the ketoconazole SmPC
结局指标
主要结局
incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole.
时间窗: up to 5 years of follow up
The primary objective is to document liver and cardiac tolerability profile of ketoconazole p.o when administered as monotherapy or in combination with other therapies, in routine clinical practice, in patients with CS.
次要结局
- Impact on Quality of life, European Quality of Life questionnaire(up to 5 years of follow up)
- Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
- Number of patients with adverse events(up to 5 years of follow up)
- Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)
- Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
- Effectiveness of ketoconazole(up to 5 years of follow up)
- Impact on Quality of life, Cushing Quality of Life questionnaire(up to 5 years of follow up)
- Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)
- Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
- Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)
研究者
研究点 (6)
Loading locations...
相似试验
招募中
不适用
Registry for Patients With X-Linked HypophosphatemiaX-Linked HypophosphatemiaNCT03193476Kyowa Kirin Pharmaceutical Development Ltd1,489
进行中（未招募）
不适用
Prospective Surveillance of Respiratory Syncytial Virus Disease in Infants and ToddlersRespiratory Syncytial Virus InfectionsNCT05964582Sanofi Pasteur, a Sanofi Company1,000
已完成
不适用
Real-world Treatment Patterns and Associated Outcomes in Patients With Resectable Early-stage Non-small Cell Lung CancerNon-small Cell Lung CancerNCT04808050AstraZeneca748
Unknown
不适用
Study Of Bacterial/Fungal Infections in Hospitalized Patients With Liver Cirrhosis in ChinaCirrhosisNCT03676777Ruijin Hospital1,232
已完成
不适用
Retrospective Study to Describe the Real-world Treatment Patterns and Associated Clinical Outcomes in Patients With Metastatic Castration-resistant Prostates CancerMetastatic Castration-resistant Prostates CancerNCT04801186AstraZeneca1,920