Active — Not RecruitingNot Applicable

Registry for Participants With Short Bowel Syndrome

United States1,806 participantsStarted 2014-06-23

Plain-language 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.

Who can participate

SexALL

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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.

What they're measuring

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

Trial details

NCT IDNCT01990040

SponsorShire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2032-06-30

View on ClinicalTrials.gov More Short Bowel Syndrome trials