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.
- •Exclusion criteria:
- •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.
排除标准
- 未提供
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 Other Malignancy(10 years)
- Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants(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 Heart Failure and Other Manifestations of Volume Overload(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)