A Non-interventional, Multicentre Retrospective Study of the Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24
研究概览
简要总结
The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada.
This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study.
The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24
时间窗: Baseline and at Week 24
Weekly volume of PN/IV fluid requirement at baseline before teduglutide treatment and at Week 24 after initiation of teduglutide treatment will be reported.
Average Change in Number of Days per Week With PN/IV Usage
时间窗: 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months
Average change in number of days per week with PN/IV usage in the 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving PN/IV Independence During the Study Period
时间窗: Up to 48 Months
Percentage of participants who will achieve PN/IV independence during the study period will be reported.
次要结局
- Change From Baseline in Weekly Volume of PN/IV Fluid Requirement(Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment)
- Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume(Up to 48 months after teduglutide treatment initiation)
- Change From Baseline in Number of Days per Week With PN/IV Usage(Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment)
- Number of Participants With Reasons of Treatment Interruption and Discontinuation(From teduglutide treatment initiation up to 48 months)
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 48 months))
- Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume(Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment)