OTHER
Non-interventional Study
This is non-interventional study.
A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada
Status
Completed
Phase
Not applicable
Enrollment
52
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
May 12, 2022
Study start
Sep 23, 2023
Primary completion
Feb 19, 2025
Study completion
Feb 19, 2025
Results posted
Not reported
Registry updated
Apr 6, 2025
Outcomes
What the study measures.
Primary outcomes
Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24
Time frame · Baseline and at Week 24
Weekly volume of PN/IV fluid requirement at baseline before teduglutide treatment and at Week 24 after initiation of teduglutide treatment will be reported.
Average Change in Number of Days per Week With PN/IV Usage
Time frame · 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months
Average change in number of days per week with PN/IV usage in the 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation will be reported.
Percentage of Participants Achieving PN/IV Independence During the Study Period
Time frame · Up to 48 Months
Percentage of participants who will achieve PN/IV independence during the study period will be reported.
Secondary outcomes
Change From Baseline in Weekly Volume of PN/IV Fluid Requirement
Time frame · Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
Change from baseline in weekly volume of PN/IV fluid requirement at 6,12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported.
Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume
Time frame · Up to 48 months after teduglutide treatment initiation
Number of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume will be reported.
Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume
Time frame · Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
Percentage of participants achieving 20% to 100% reduction from baseline in weekly PS volume at 6, 12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported.
Change From Baseline in Number of Days per Week With PN/IV Usage
Time frame · Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
Change from baseline in number of days per week with PN/IV usage at 6,12, 24, 36 and 48 months after teduglutide treatment initiation will be reported.
Number of Participants With Reasons of Treatment Interruption and Discontinuation
Time frame · From teduglutide treatment initiation up to 48 months
Number of participants with reasons of treatment interruption and discontinuation will be reported.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame · From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 48 months)
An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Canada. Showing up to 24 locations stored in the fast local snapshot.
Innomar Strategies
Oakville, Ontario, Canada
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.