CompletedNot Applicable

A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada

Canada52 participantsStarted 2023-09-23

Plain-language summary

The main aim of this study is to assess the effectiveness and side effects of teduglutide (Revestive®) in real-world clinical practice setting in adult participants with intestinal failure due to short bowel syndrome (SBS-IF) in Canada. This study is about collecting existing data only; participants receive teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. No new information will be collected during this study. The study will be conducted using data from the Takeda OnePath Patient Support Program (PSP) or Takeda Global Pharmacovigilance.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * Participants more than or equal to (\>=) 18 years of age at first dose of teduglutide diagnosed with intestinal failure due to short bowel syndrome as a result of intestinal resection. Note: As "SBS as result of major intestinal resection" is a criterion for teduglutide treatment reimbursement, it is assumed that all participants receiving teduglutide in the PSP have SBS-IF as a result of intestinal resection. * Stable participants with SBS-IF who were dependent on parenteral support prior to teduglutide treatment initiation, and were treated with teduglutide during the study period with at least 6 months of follow-up data available before the end of the study period. * Participants who have provided informed consent for secondary use of data for research. Exclusion criteria: \- Participants with active gastrointestinal malignancy OR a history of gastrointestinal malignancy in the past 5 years before start of treatment.

What they're measuring

Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24

Timeframe: Baseline and at Week 24

Average Change in Number of Days per Week With PN/IV Usage

Timeframe: 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months

Percentage of Participants Achieving PN/IV Independence During the Study Period

Timeframe: Up to 48 Months

Trial details

NCT IDNCT05371028

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-02-19

View on ClinicalTrials.gov More Short Bowel Syndrome (SBS) trials