JPRN-jRCT2080224109已完成4 期
An open-label, multi-center, roll-over study to assess long term safety in patients with endogenous Cushing's syndrome who have completed a prior Novartis-sponsored osilodrostat (LCI699) study and are judged by the investigator to benefit from continued treatment with osilodrostat
Recordati Rare Diseases Japan K.K0 个研究点目标入组 180 人开始时间: 2018年10月23日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •Primary inclusion criteria
- •- Patients who have completed a Global Novartis-sponsored study receiving osilodrostat.
- •- Patients who will continue to benefit from treatment with osilodrostat, as judged by the investigator.
- •- Patient has demonstrated compliance, as assessed by the Investigator, with the parent study protocol requirements.
- •- Willingness and ability to comply with scheduled visits and treatment plans.
- •- Written informed consent obtained prior to enrolling into the roll-over study .
排除标准
- •Primary exclusion criteria
- •- Patients who have been permanently discontinued from osilodrostat study treatment in a parent Novartis-sponsor study.
- •- Patients who are receiving osilodrostat in combination with unapproved or experimental treatments.
- •- Pregnant or nursing (lactating) women.
研究者
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