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

Shire1 site in 1 country1,806 target enrollmentJune 23, 2014

ConditionsShort Bowel Syndrome

Overview

Phase: N/A
Intervention: Not specified
Conditions: Short Bowel Syndrome
Sponsor: Shire
Enrollment: 1806
Locations: 1
Primary Endpoint: 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
Status: Active, Not Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 23, 2014

End Date

June 30, 2032

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

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.

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

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)