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
Photo 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

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

Lead Scientist at UCSF

  • Sue Rhee, MD
    Division Chief, Pediatric Gastroenterology, Hepatology, and Nutrition Anita Ow Wing Endowed Chair Medical Director, Pediatric Liver Transplant Program Medical Director, Pediatric Intestinal Rehabilitation Program Co-Director, Pediatric Pancreas Program Fellowship Director, Pediatric Transplant Hepatology

Details

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