Registry for Participants With Short Bowel Syndrome

N/AActive Not RecruitingNCT01990040

Shire1,806 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,806

Conditions

Short Bowel Syndrome

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (1)

Shire

Lexington, Massachusetts, United States

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

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.

Time frame: 10 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 10 years

Actual Volume Change in Parenteral Support (PS)