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

Takeda52 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Short Bowel Syndrome (SBS)

Interventions

Non-interventional StudyOTHER

This is non-interventional study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Innomar Strategies

Oakville, Ontario, Canada

Outcomes

Primary Outcomes

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

Time frame: Baseline and at Week 24

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

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.

Time frame: 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

Percentage of participants who will achieve PN/IV independence during the study period will be reported.

Time frame: Up to 48 Months

Secondary Outcomes

Change From Baseline in Weekly Volume of PN/IV Fluid Requirement

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.

Time frame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment

Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume

Number of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume will be reported.

Time frame: Up to 48 months after teduglutide treatment initiation

Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume

Data from ClinicalTrials.gov

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