NCT01560403已完成3 期
A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 14
- 试验地点
- 5
- 主要终点
- Summary of Treatment-emergent Adverse Events
研究概览
简要总结
This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.
详细描述
This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
- •Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
- •Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed
排除标准
- 未提供
研究组 & 干预措施
Teduglutide
Experimental
0.05 mg/kg/day
干预措施: Teduglutide (Drug)
结局指标
主要结局
Summary of Treatment-emergent Adverse Events
时间窗: 12 months
As the primary intent of this study was to collect additional safety data, this outcomes measure will provide a summary of the treatment emergent adverse events. Based on the start date of each subject in this study and the study end date, not all subjects reached 12 months.
次要结局
未报告次要终点
研究者
研究点 (5)
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