Purpose

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.

Condition

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts 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.

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Teduglutide treated SBS participants who have been treated with teduglutide.
Non-teduglutide treated SBS participants who have not been treated with teduglutide.

Recruiting Locations

Vanderbilt University Medical Center Diagnostic Lab
Nashville, Tennessee 37232
Contact:
Douglas Seidner
615-322-4643
douglas.seidner@vanderbilt.edu

More Details

NCT ID
NCT01990040
Status
Recruiting
Sponsor
Shire

Study Contact

Shire Contact
1 866-842-5335
clinicaltransparency@shire.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.