Non-interventional, Multicenter Retrospective Study of the Effectiveness and Safety of Teduglutide (Revestive®) in Short Bowel Syndrome Adult Patients in Spain (T-Rex Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 6
研究概览
简要总结
The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®).
This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected during this study. Only data already available in the hospital records will be reviewed and collected for this study.
Participants do not need to visit their doctor in addition to their normal visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Participants >= 18 years of age diagnosed with intestinal failure due to SBS as a result of intestinal resection.
- •SBS-IF participants treated with teduglutide according to Summary of Product Characteristics (SmPC).
- •Patients who receive or have received teduglutide for at least six months at the date of inclusion (from treatment initiation to inclusion date, date of discontinuation, death for any cause or loss of follow-up).
- •When required by the ethics committee of the center: participants who have signed the informed consent form (ICF) to participate in the study.
排除标准
- •Participants who do not meet the inclusion criteria.
结局指标
主要结局
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 6
时间窗: Month 6
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 6 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 12
时间窗: Month 12
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 12 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 18
时间窗: Month 18
Percentage of participants achieveing response of 20% to 100% reduction from baseline in weekly PS volume at Month 18 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Month 1
时间窗: Month 1
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 1 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 2
时间窗: Month 2
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 2 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 3
时间窗: Month 3
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 3 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 24
时间窗: Month 24
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 24 after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume at Month 9
时间窗: Month 9
Percentage of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume at Month 9 after teduglutide treatment initiation will be reported.
次要结局
- Median Time to Achieve Independence From PN and IV Fluid Support(Up to Month 24)
- Average Change in Body Mass Index (BMI)(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Average Change in Number of Days per Week With PN/IV Usage(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Median Time to Achieve any Response After Teduglutide Treatment Initiation.(Up to Month 24)
- Average Change in Daily Urine Volume(6 months before teduglutide treatment initiation up to Months 1, 2, and 3 after teduglutide treatment initiation)
- Number of Participants who Discontinued Treatment due to any Cause(Up to Month 24)
- Average Change in PN/IV Caloric Intake(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Number of Participants With Independence From PN and IV Fluid Support(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Average Change in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Requirement(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Number of Participants Achieving Response of 20% to 100% Reduction From Baseline in Weekly PS Volume(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Time to Achieve Response up to Month 24(Baseline up to Month 24)
- Average Change in Stool Characteristics(6 months before teduglutide treatment initiation up to Month 6 after teduglutide treatment initiation)
- Average Change in Daily Fluids Intake(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Average Change in Daily Calories Oral Intake(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Average Change in Blood Parameters Such as Serum Albumin and Serum Pre-albumin(6 months before teduglutide treatment initiation up to Months 1, 2, 3, 6, 9, 12, 18 and 24 after teduglutide treatment initiation)
- Number of Participants With Adverse Events (AEs)(Up to Month 6 after teduglutide treatment discontinuation)