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

Recruiting

• Conditions: Short Bowel Syndrome (SBS)
• Interventions: Other: Non-interventional Study

• Registration Number: NCT05371028
• Lead Sponsor: Takeda

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-28
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-12
• Study Start: 2023-09-23
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-12
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With SBS-IF	Non-interventional Study	Participants with SBS-IF who as part of standard or routine clinical practice, must have received teduglutide (Revestive®) treatment and were dependent on parenteral support prior to teduglutide treatment initiation will be observed in this retrospective observational study for up to 48 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24	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	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	Up to 48 Months	Percentage of participants who will achieve PN/IV independence during the study period will be reported.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Weekly Volume of PN/IV Fluid Requirement	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	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.
Change From Baseline in Number of Days per Week With PN/IV Usage	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	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)	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.
Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume	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.

Trial Locations

Locations (1)

Innomar Strategies; 🇨🇦 Oakville, Ontario, Canada