Registry for Participants With Short Bowel Syndrome

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01990040
• Other study ID #: TED-R13-002
• Secondary ID: EUPAS7973
• Status: Active, not recruiting
• Start date: June 23, 2014
• Est. completion date: April 30, 2033

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. SBS participants treated and not treated with teduglutide will be enrolled.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• Est. completion date: April 30, 2033
• Est. primary completion date: April 30, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Shire	Lexington	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Takeda Development Center Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years
Secondary	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.	10 years

External Links

•   To obtain more information on the study, click here/on this link