EUCTR2018-003062-13-FR进行中（未招募）1 期
A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Phase 2b and Phase 3 Core
- •1. Diagnosis of PWS confirmed by deoxyribonucleic acid (DNA) methylation test.
- •2. Male and female patients 8 to 65 years of age, inclusive.
- •3. Have evidence of increased appetite or Hyperphagia
- •Phase 2b and 3 Extension
- •Patients must have participated in the core period.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 30
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Core Period
- •1. History of chronic liver disease, such as cirrhosis or chronic hepatitis due to any cause, or suspected alcohol abuse.
- •2. History of significant cardiovascular disease including history of congestive heart failure CHF, New York Heart Association [NYHA] Class 3 or 4), angina pectoris, or
- •myocardial infarction (MI) within 6 months prior to screening.
- •3. Type 1 diabetes mellitus.
- •4. Glycated hemoglobin (HbA1c) >10%.
- •5. History of frequent hypoglycaemia.
- •A patient who enrolled in the Phase 2b part is not eligible for recruitment in the Phase 3 part.
研究者
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