Short Bowel SyndromeNCT01990040
Registry for Participants With Short Bowel Syndrome
An observational study of Short Bowel Syndrome, run by Shire at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Short Bowel Syndrome
- How many people
- 1,806 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2014to 30 Jun 2032
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This registry is to enroll both male and female adult participants, of any age, with a diagnosis of SBS.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Short Bowel Syndrome
- Keywords
- Short Bowel Syndrome, SBS, teduglutide, Gattex
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Teduglutide treated | SBS participants who have been treated with teduglutide. | |
| Non-teduglutide treated | SBS participants who have not been treated with teduglutide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study start23 Jun 2014
- Primary completion30 Jun 2032 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,806 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Takeda Development Center Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990040
- Sponsor's protocol ID
- TED-R13-002
- Other IDs
- EUPAS7973
- Status last verified
- Sep 2026
- First submitted
- 11 Nov 2013
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.