Registry for Participants With Short Bowel Syndrome

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Short Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 1800

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Lexington, Massachusetts, United States, 02421
      • Shire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This registry is to enroll both male and female adult participants, of any age, with a diagnosis of SBS.

Description

Inclusion Criteria:

1. Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS).
2. Signed informed consent and medical records release by the participant or a legally acceptable representative
3. 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:

1. Participants currently participating in a blinded clinical trial or their extension studies.
2. Participants who have never been on PN/IV support.
3. Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Teduglutide treated; SBS participants who have been treated with teduglutide.
Non-teduglutide treated; SBS participants who have not been treated with teduglutide.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shire
• Collaborators: Takeda Development Center Americas, Inc.
• Investigators: Study Director: Study Director, Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2014
• Primary Completion (Estimated): April 30, 2033
• Study Completion (Estimated): April 30, 2033

Study Registration Dates

• First Submitted: November 11, 2013
• First Submitted That Met QC Criteria: November 15, 2013
• First Posted (Estimated): November 21, 2013

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Short Bowel Syndrome; SBS; teduglutide; Gattex
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: TED-R13-002; EUPAS7973 (Other Identifier: ENCePP EU PAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No