Registry for Participants With Short Bowel Syndrome

Shire

Status: Active, not recruiting

Conditions: Short Bowel Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01990040

TED-R13-002

EUPAS7973 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,806 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

1,806 participants in 2 patient groups

Teduglutide treated

Description:

SBS participants who have been treated with teduglutide.

Non-teduglutide treated

Description:

SBS participants who have not been treated with teduglutide.