Continuation of an Open-label, Multi-center Study to Assess Long Term Safety in Canadian Patients With Endogenous Cushing's Syndrome Who Have Completed Prior Recordati-sponsored Osilodrostat (LCI699) Study LCI699C2X01B and Are Judged by the Investigator to Benefit From Continued Treatment With Osilodrostat
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- Number of participants with adverse/serious adverse events
研究概览
简要总结
The purpose of this study is to continue the evaluation of long-term safety of osilodrostat in 7 Canadian patients who have already received osilodrostat treatment in a previous Global Recordati-sponsored roll-over study and who, based on investigators' judgement, will continue benefiting with its administration.
详细描述
There will be no screening period for this study. Eligible subjects can start their treatment with osilodrostat as soon as they are enrolled in the study. The first study visit will be scheduled at the time of the last study visit for the parent study. Subjects must return to the study center at least on a quarterly basis (every 12 weeks ± 2 weeks) for safety and clinical benefit assessments, and resupply of study medication. Drug dispensing and administration information and adverse events will be collected. The subject may return to the clinic at any given time as per standard of care or treating physician recommendation; however, only the quarterly study visits will be recorded in the Case Report Form (CRF). Study medication dispensed will be recorded in the CRF dose administration page.
All adverse events and serious adverse events, including pregnancy, will be collected throughout the study. Subjects will continue to be treated in this roll-over study until they are no longer benefiting from their osilodrostat treatment as judged by the Investigator or until osilodrostat is commercially available or until one of other discontinuation criteria is met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is currently participating in a Global Recordati-sponsored roll-over study receiving osilodrostat for any type of endogenous CS and has fulfilled all their requirements in the parent study.
- •The patient is currently benefiting from treatment with osilodrostat, as determined by the Investigator.
- •Patient has demonstrated compliance, as assessed by the Investigator, with the parent roll-over study protocol requirements.
- •Willingness and ability to comply with scheduled visits and treatment plans.
- •Written informed consent obtained prior to enrolling into the study
排除标准
- •Patient has been permanently discontinued from osilodrostat study treatment in the parent roll-over Recordati-sponsored study.
- •New patients not previously enrolled in parent roll-over Recordatisponsored study.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory evaluation.
研究组 & 干预措施
Participant Group/Arm
Other: osilodrostat
open label, with patients receiving same dose as provided in the parent study
干预措施: Intervention/Treatment (Drug)
结局指标
主要结局
Number of participants with adverse/serious adverse events
时间窗: up to 2 years
To evaluate long term safety
次要结局
- Percentage of patients with clinical benefit(up to 2 years)