Clinical trial NCT01990040: Registry for Participants With Short Bowel Syndrome
Official title: A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Short Bowel Syndrome
Keywords: Short Bowel Syndrome
SBS
teduglutide
Gattex
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2013-11-21
Enrollment: 1806
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This registry is to enroll both male and female adult participants, of any age, with a diagnosis of SBS.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 10 years
Secondary outcomes:
measure: Occurrence of Other Malignancy
timeFrame: 10 years
measure: Occurrence of Benign Neoplasia of the Gastrointestinal (GI) tract, Hepatobiliary System, and Pancreas in Participants
timeFrame: 10 years
measure: Occurrence of Colorectal Polyps
timeFrame: 10 years
measure: Occurrence of Intestinal Obstruction
timeFrame: 10 years
measure: Occurrence of Pancreatic and Biliary Disease
timeFrame: 10 years
measure: Occurrence of Heart Failure and Other Manifestations of Volume Overload
timeFrame: 10 years
measure: Occurrence of Allergic/Hypersensitivity Reaction to Teduglutide
timeFrame: 10 years
measure: Occurrence of Other Adverse Events (AEs) Potentially Related to Treatment with Teduglutide
timeFrame: 10 years
measure: Actual Volume Change in Parenteral Support (PS)
timeFrame: 10 years
measure: Percentage Volume Change in Parenteral Support (PS)
timeFrame: 10 years
measure: Actual Change in the Number of Days per Week on Parenteral Support (PS)
timeFrame: 10 years
measure: Percentage Change in the Number of Days per Week on Parenteral Support (PS)
timeFrame: 10 years
measure: Percent of Participants Weaning From Parental Support (PS)
timeFrame: 10 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Shire
state: Massachusetts
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: