EUCTR2018-001833-42-GB进行中（未招募）1 期
A double-blind, placebo-controlled, randomized withdrawal study to evaluate the safety, pharmacokinetics and efficacy of CRN00808 in patients with acromegaly that are responders to octreotide LAR or lanreotide depot (ACROBAT EVOLVE) - ACROBAT EVOLVE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
入选标准
- •1.Male and female subjects 18 to 75 years of age;
- •2.Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
- •3.Females must be non-pregnant and non-lactating, a;nd 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 38
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Treatment naïve acromegaly subjects
- •2.Prior treatment with CRN00808
- •3.Pituitary surgery within 6 months prior to Screening or pituitary
- •radiation therapy at any time prior to the study entry (If a subject 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
- •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 who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months);
- •13.Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg;
- •14.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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