Registry for Participants With Short Bowel Syndrome

a study on Short Bowel Syndrome

Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Prospective, Multi-center Registry for Patients With Short Bowel Syndrome

Details

22-APR-2020: Enrollment of new participants into this study continues according to discretion and availability of sites during the COVID-19 situation, however, enrollment of new sites has been paused due to the COVID-19 situation. The duration of this pause is dependent on the leveling and control of the COVID-19 pandemic.

Keywords

Short Bowel Syndrome SBS teduglutide Gattex Syndrome

Eligibility

You can join if…

  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.

You CAN'T join if...

  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.

Locations

  • UCSF Benioff Children's Hospital accepting new patients
    San Francisco California 94158 United States
  • Northwest Gastroenterology Clinic, LLC completed
    Portland Oregon 97210 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
ID
NCT01990040
Study Type
Observational [Patient Registry]
Last Updated
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