Registry for Participants With Short Bowel Syndrome
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
- Short Bowel Syndrome
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
| Arm | Description | Assigned Intervention |
|---|---|---|
| Teduglutide treated | SBS participants who have been treated with teduglutide. | |
| Non-teduglutide treated | SBS participants who have not been treated with teduglutide. |
More Details
- Status
- Active, not recruiting
- Sponsor
- Shire