NCT04261712终止2 期
An Open Label, Long-term Extension Study to Evaluate the Safety and Efficacy of CRN00808 in Subjects With Acromegaly (ACROBAT Advance)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 43
- 试验地点
- 25
- 主要终点
- Incidence of treatment-emergent adverse events (TEAEs) throughout the study
研究概览
简要总结
A phase 2, open label, long-term extension study designed to evaluate the safety and efficacy of paltusotine (formerly CRN00808; an oral selective nonpeptide somatostatin receptor type 2 biased agonist) in subjects with acromegaly.
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
- •Completed one of the parent studies (Acrobat Evolve [CRN00808-02] or Acrobat Edge [CRN00808-03])
- •Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
- •Willing to provide signed informed consent
排除标准
- •Clinically significant concomitant disease including, but not limited to, cardiovascular disease; moderate or severe renal insufficiency; or significant liver disease (including cirrhosis)
- •Pituitary radiation since completing participation in parent studies
- •History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years
- •Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab).
- •History of alcohol or substance abuse in the past 12 months
- •Use of any investigational drug (other than paltusotine) within the past 30 days or 5 half-lives, whichever is longer before Screening
- •Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study.
- •Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities
- •Subjects with symptomatic cholelithiasis
- •Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
研究组 & 干预措施
Paltusotine
Experimental
干预措施: Paltusotine (Drug)
结局指标
主要结局
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
时间窗: Week 316
次要结局
- Change in insulin-like growth factor-1 (IGF-1) level(Week 16, Week 312)
- Change in growth hormone (GH) level(Week 16, Week 312)
研究者
研究点 (25)
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