EUCTR2009-011679-65-GB进行中（未招募）1 期
A Long Term, Open Label Study with Teduglutide for Subjects with Parenteral Nutrition Dependent Short Bowel Syndrome
PS Pharmaceuticals0 个研究点目标入组 84 人开始时间: 2010年3月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 84
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
- •Subjects who meet all of the following criteria can be enrolled in this study:
- •1. Completion of 24-weeks of dosing in Study CL0600-020 or based on investigator and sponsor decision if the subject was required to stop dosing prematurely due to a non-drug related adverse experience or successful completion of stage I (optimization/stabilization) in Study CL0600-020 (i.e. qualification for randomization) after approximately 86 subjects have been randomized.
- •2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study CL0600-021 are performed.
- •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 71
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 17
排除标准
- •Exclusion criteria do not apply as only those subjects who have participated in Study CL0600-020 and do not meet the events necessitating withdrawal from the study as listed in Section 4.4.2 of this protocol are eligible.
研究者
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