EUCTR2010-021523-28-DE进行中（未招募）不适用
A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients with Growth Hormone Deficiency (AGHD)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
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 or female between 20 to 70 years
- •2.Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive
- •3.Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (Ho, 2007)
- •4.Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
- •5.GH replacement therapy for at least 3 months
- •6.Willing to maintain current activity level during the trial
- •7.Subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with Good Clinical Practice (GCP
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
- •2.Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
- •3.Active malignant disease or malignant disease within the last 5 years
- •4.Proliferative retinopathy judged by retina-photo within the last year
- •5.Heart insufficiency as judged by the investigator and/or NYHA 3 or greater
- •6.Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment
- •7.Stable pituitary replacement therapy for less than 3 months
- •8.Impaired liver function as judged by the investigator or h (hepatic transaminases > 2 times the upper limit of normal
- •9.Impaired kidney function as judged by the investigator and/or (creatinine clearance <50 ml/min and/or serum creatinine > 1,4 mg/dL
- •10.Participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or during the study.
- •11.Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
- •12.History or presence of alcohol abuse or drug abuse.
- •13.Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies
研究者
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