Registry for Participants With Short Bowel Syndrome
A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
2 other identifiers
observational
1,806
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2013
CompletedFirst Posted
Study publicly available on registry
November 21, 2013
CompletedStudy Start
First participant enrolled
June 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2032
October 10, 2025
October 1, 2025
18 years
November 11, 2013
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (13)
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 Intestinal Obstruction
10 years
Occurrence of Pancreatic and Biliary Disease
10 years
- +8 more secondary outcomes
Study Arms (2)
Teduglutide treated
SBS participants who have been treated with teduglutide.
Non-teduglutide treated
SBS participants who have not been treated with teduglutide.
Eligibility Criteria
This registry is to enroll both male and female adult participants, of any age, with a diagnosis of SBS.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (1)
Shire
Lexington, Massachusetts, 02421, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Shire
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2013
First Posted
November 21, 2013
Study Start
June 23, 2014
Primary Completion (Estimated)
June 30, 2032
Study Completion (Estimated)
June 30, 2032
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.