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Clinical Trials in the USA / NCT01990040
Active, not recruiting Observational

Registry for Participants With Short Bowel Syndrome

NCT01990040 · tracked via the Priya Life Science USA tracker
Sponsor
Shire
Phase
Observational
Started
2014-06-23
Last updated
2026-09-23

Condition(s) studied

Short Bowel Syndrome

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Shire Lexington Massachusetts

More Shire trials in the USA

Gaucher Disease Outcome Survey (GOS) Recruiting

Other trials for the same condition

Open-label Extension Trial to Evaluate the Long-term Safety of Apraglutide in Short Bowel Syndrome. Active, not recruiting
Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS Recruiting
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01990040 on ClinicalTrials.gov ↗ ← All trials in the USA