跳至主要内容
临床试验/NCT03604198
NCT03604198进行中(未招募)2 期

An Open-Label Extension Study of the Safety of Relacorilant (CORT125134) in the Treatment of the Signs and Symptoms of Endogenous Cushing Syndrome

Corcept Therapeutics86 个研究点 分布在 8 个国家目标入组 125 人开始时间: 2018年5月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
125
试验地点
86
主要终点
Long-term safety of relacorilant

研究概览

简要总结

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

详细描述

This study is designed to allow continued therapy with relacorilant, a potent, selective glucocorticoid receptor (GR) antagonist in patients who have successfully completed participation of a Corcept-sponsored study of relacorilant (referred to as the "parent" study). Patients may qualify to enter this extension study if they complete their last treatment visit in their parent study and in the Investigator's opinion will benefit from continued treatment.

Once-daily dosing with relacorilant may continue for patients who receive clinical benefits (as judged by the Investigator) until relacorilant is commercially or otherwise available or the study is stopped by the Sponsor. A patient's dose may be maintained, reduced, or increased based on individual response and tolerability.

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

性别
All
接受健康志愿者

入选标准

  • Major Inclusion Criteria:
  • Have completed a Corcept-sponsored study of relacorilant in endogenous Cushing syndrome
  • According to the Investigator's opinion will benefit from continuing treatment with relacorilant.

排除标准

  • Major Exclusion Criteria:
  • Premature discontinuation from a relacorilant parent study
  • Has uncontrolled, clinically significant hypothyroidism or hyperthyroidism.

研究组 & 干预措施

relacorilant (CORT125134)

Experimental

干预措施: relacorilant (Drug)

结局指标

主要结局

Long-term safety of relacorilant

时间窗: 36 months

Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (86)

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