EUCTR2018-002230-20-DE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 75 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 subjects in
- •Group 3, 4, or 5 who have undergone pituitary radiation therapy at any
- •time prior to the study entry. A history of radiation therapy is not a
- •restriction for subjects in Group 1 or 2. If a subject in Group 3, 4, or 5
- •has undergone pituitary radiation therapy =4 years prior to Screening
- •and has had a documented IGF-1 =1.3×ULN within 2 years prior to Screening OR if a subject has undergone pituitary radiation therapy between 3 and 4 years prior to Screening and has had a documented IGF-1 =1.3×ULN within 1 year
- •prior to Screening, the subject may be included in the study;
- •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.Subjects with hepatitis B, Human Immunodeficiency Virus (HIV), or
- •hepatitis C infection. Subjects with previous hepatitis C infection that is
- •now cured may be eligible.
- •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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