EUCTR2004-000439-27-DK进行中（未招募）1 期
A Study of the Safety and Efficacy of Teduglutide in Subjects with Parenteral Nutrition-Dependant Short Bowel Syndrome Who Completed Protocol CL0600-004 - N/A
PS Allelix Corporation0 个研究点目标入组 80 人开始时间: 2005年4月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •Subjects who meet all of the following criteria can be enrolled in this study:
- •1. Signed and dated informed consent form (ICF) before any study-related
- •procedures are performed
- •2. Completion of protocol CL0600-004
- •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
- •Subjects who meet any of the following criteria will be excluded:
- •1. History of cancer or clinically significant lymphoproliferative disease with
- •fewer than 5 years documented disease-free state. This does not include
- •resected cutaneous basal or squamous cell carcinoma, or in situ cervical
- •2. History of alcohol or drug abuse (within previous year)
- •3. Prior use of native GLP-2 within 3 months of screening visit
- •4. Pregnant or lactating women
- •5. Any condition or circumstance, which in the investigator’s opinion would put
- •the subject at any undue risk, prevent completion of the study, or interfere with
- •analysis of the study results
- •6. Failure to adhere to required washout periods
研究者
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