A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Shire
- 入组人数
- 1,806
- 试验地点
- 1
- 主要终点
- Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide
研究概览
简要总结
This is a global prospective, observational, multi-center registry to evaluate the long-term safety profile for participants with short bowel syndrome (SBS) who are treated with teduglutide in a routine clinical setting. The registry will also evaluate the long-term clinical outcomes in participants with SBS. SBS participants treated and not treated with teduglutide will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
- •Signed informed consent and medical records release by the participant or a legally acceptable representative
- •Participants who have never received teduglutide treatment must be on parenteral nutrition (PN)/intravenous (IV) fluids support for at least 6 months at the time of enrollment.
排除标准
- •Participants currently participating in a blinded clinical trial or their extension studies.
- •Participants who have never been on PN/IV support.
- •Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.
研究组 & 干预措施
Non-teduglutide treated
SBS participants who have not been treated with teduglutide.
Teduglutide treated
SBS participants who have been treated with teduglutide.
结局指标
主要结局
Occurrence of Colorectal Cancer in Short Bowel Syndrome (SBS) Participants With a Remnant Colon Currently Being Treated With or Ever Having Been Treated With Teduglutide
时间窗: 10 years
Incidence rates of colorectal cancer in participants will be calculated by dividing the number of incident colorectal cancer cases by the total number of person-years observed since beginning treatment with teduglutide.
次要结局
- Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants(10 years)
- Occurrence of Heart Failure and Other Manifestations of Volume Overload(10 years)
- Occurrence of Other Malignancy(10 years)
- Occurrence of Colorectal Polyps(10 years)
- Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide(10 years)
- Occurrence of Intestinal Obstruction(10 years)
- Occurrence of Pancreatic and Biliary Disease(10 years)
- Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide(10 years)
- Actual Volume Change in Parenteral Support (PS)(10 years)
- Percentage Volume Change in Parenteral Support (PS)(10 years)
- Actual Change in the Number of Days per Week on Parenteral Support (PS)(10 years)
- Percentage Change in the Number of Days per Week on Parenteral Support (PS)(10 years)
- Percent of Participants Weaning From Parental Support (PS)(10 years)