Registry for Participants With Short Bowel Syndrome

Sponsor

Shire (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT01990040

Collaborator

Takeda Development Center Americas, Inc. (Industry)

1,800

Enrollment

Location

226.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Short Bowel Syndrome

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1800 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 23, 2014

Anticipated Primary Completion Date :

Apr 30, 2033

Anticipated Study Completion Date :

Apr 30, 2033

Arms and Interventions

Arm	Intervention/Treatment
Teduglutide treated SBS participants who have been treated with teduglutide.
Non-teduglutide treated SBS participants who have not been treated with teduglutide.

Outcome Measures

Primary Outcome Measures

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 [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 Outcome Measures

Occurrence of Other Malignancy [10 years]
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.
Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants [10 years]
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.
Occurrence of Colorectal Polyps [10 years]
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.
Occurrence of Intestinal Obstruction [10 years]
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.
Occurrence of Pancreatic and Biliary Disease [10 years]
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.
Occurrence of Heart Failure and Other Manifestations of Volume Overload [10 years]
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.
Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide [10 years]
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.
Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide [10 years]
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.
Actual Volume Change in Parenteral Support (PS) [10 years]
PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Percentage Volume Change in Parenteral Support (PS) [10 years]
PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Actual Change in the Number of Days per Week on Parenteral Support (PS) [10 years]
PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Percentage Change in the Number of Days per Week on Parenteral Support (PS) [10 years]
PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.
Percent of Participants Weaning From Parental Support (PS) [10 years]
PS will be measured by parenteral treatment volume (liters/week) and days (days/week) that occurred in the 7 days prior to the visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.