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
Principal Investigator
by Sue Rhee, MD
Headshot of Sue Rhee
Sue Rhee

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

28-MAY-2021: Enrollment of new Teduglutide treated adult participants into this study continues according to discretion and availability of sites during the COVID-19 situation, however, enrollment of untreated adult participants and pediatrics patients was stopped on the 30th April 2021 as the targets in these cohorts had been met. Enrollment of new Teduglutide treated adult participants is expected to be prolonged until 2022.

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
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027-6062 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSF

  • Sue Rhee, MD
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 29 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Shire
Links
To obtain more information on the study, click here/on this link
ID
NCT01990040
Study Type
Observational [Patient Registry]
Participants
Expecting 1310 study participants
Last Updated
Contact us about this trial