Registry for Participants With Short Bowel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

Conditions
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Short Bowel Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Teduglutide treated<br>SBS participants who have been treated with teduglutide. | |
| Non-teduglutide treated<br>SBS participants who have not been treated with teduglutide. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Other Malignancy | Incidence rates of other malignancies will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants | Incidence rates of benign neoplasia of the GI tract, hepatobiliary system, and pancreas will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Colorectal Polyps | Incidence rates of colorectal polyps will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Intestinal Obstruction | Incidence rates of intestinal obstruction will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Pancreatic and Biliary Disease | Incidence rates of pancreatic and biliary disease will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Heart Failure and Other Manifestations of Volume Overload | Incidence rates of heart failure and other manifestations of volume overload will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide | Incidence rates of allergic/hypersensitivity reactions to teduglutide will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. | 10 years | 
| Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide | Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. Incidence rates of other AEs will be calculated by dividing the number of incident cases by the total number of person-years observed since beginning treatment with teduglutide. An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product (ICH Guidance E2A 1995). This includes an exacerbation of a pre-existing condition. | 10 years | 
| Actual Volume Change in Parenteral Support (PS) | PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit. | 10 years | 
| Percentage Volume Change in Parenteral Support (PS) | PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit. | 10 years | 
| Actual Change in the Number of Days per Week on Parenteral Support (PS) | PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit. | 10 years | 
| Percentage Change in the Number of Days per Week on Parenteral Support (PS) | PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit. | 10 years | 
| Percent of Participants Weaning From Parental Support (PS) | PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit. | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Short Bowel Syndrome, SBS, teduglutide, Gattex