Registry for Participants With Short Bowel Syndrome

  • STATUS
    Recruiting
  • End date
    May 31, 2031
  • participants needed
    1310
  • sponsor
    Shire
Updated on 21 June 2021
teduglutide

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.

Description

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.

Details
Condition Short Bowel Syndrome
Clinical Study IdentifierNCT01990040
SponsorShire
Last Modified on21 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female participants, of any age, with a diagnosis of short bowel syndrome (SBS)
Signed informed consent and medical records release by the participant or a legally acceptable representative
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
Participants who have never been on PN/IV support
Participants who are currently or previously exposed to any Glucagon-like peptide 2 (GLP-2) analogs other than teduglutide
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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