Status:
COMPLETED
A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada
Lead Sponsor:
Takeda
Conditions:
Short Bowel Syndrome (SBS)
Eligibility:
All Genders
18+ years
Brief 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 shor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 23 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 19 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT05371028
Start Date
September 23 2023
End Date
February 19 2025
Last Update
April 6 2025
Active Locations (1)
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1
Innomar Strategies
Oakville, Ontario, Canada, L6L 0C4