EUCTR2018-002230-20-IT进行中（未招募）1 期
An open label exploratory study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly treated with somatostatin analogue based treatment regimens (ACROBAT EDGE) - ACROBAT EDGE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female subjects 18 to 70 years of age
- •2.Confirmed diagnosis of acromegaly with either a partial or complete response to protocol defined somatostatin analogue therapy regimens
- •3.Females must be non-pregnant and non-lactating, and either surgically
- •sterile, post-menopausal, or using effective method(s) of birth control
- •4.Willing to provide signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1.Treatment naïve acromegaly subjects
- •2.Prior treatment with CRN00808
- •3.Pituitary surgery within 6 months prior to Screening or radiation
- •therapy at any time prior to the study entry;
- •4.History or presence of malignancy except adequately treated basal cell
- •and squamous cell carcinomas of the skin within the past 5 years.
- •5.Use of any investigational drug within the past 30 days or 5 half-lives,
- •whichever is longer
- •6.Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg)or hepatitis C antibody (HCV-Ab) or has a history of a positive result
- •7.History of alcohol or substance abuse in the past 12 months
- •8.Any condition that in the opinion of the investigator would jeopardize
- •the subject's appropriate participation in this study
- •9.Cardiovascular conditions or mediations associated with prolonged QT
- •or those which predispose subjects to heart rhythm abnormalities.
- •10.Subjects with symptomatic cholelithiasis
- •11.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
- •12.Subjects taking octreotide LAR at a dose higher than 40 mg, or lanreotide depot at a dose higher than 120 mg, or pasireotide LAR at a dose higher than 60 mg;
- •13.Subjects who usually take octreotide LAR or lanreotide depot less
- •frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks);
研究者
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