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

Study Overview
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Brief Summary
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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. Only standard care information available in the participant's medical charts will be reviewed and collected for this study.

Official Title
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A Non-interventional, Multicentre Retrospective Study of the Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada

Conditions
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Short Bowel Syndrome (SBS)

Intervention / Treatment
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* Other: Non-interventional Study


Participation Criteria
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Eligibility Criteria
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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. 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. When required by the ethics committee of the centre: Participants who have signed the informed consent form (ICF) to participate in the study. Exclusion criteria: - Participants with active gastrointestinal malignancy OR a history of gastrointestinal malignancy in the past 5 years before start of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With SBS-IF<br>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 18 months. | Other: Non-interventional Study<br>* This is non-interventional study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Up to 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Weekly Volume of PN/IV Fluid Requirement | Change from baseline in weekly volume of PN/IV fluid requirement at 3, 6,12 and 18 months after initiation of treatment with teduglutide will be reported. | Baseline and at 3, 6, 12 and 18 months after initiation of teduglutide treatment | 
| Time To Achieving 20 Percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume | Time to achieving 20% to 100% reduction from baseline in weekly PS Volume at 3, 6, 12 and 18 months will be reported. | At 3, 6, 12 and 18 months after teduglutide treatment initiation | 
| Change From Baseline in Number of Days per Week With PN/IV Usage | Change from baseline in number of days per week with PN/IV usage at 3, 6,12 and 18 months after teduglutide treatment initiation will be reported. | Baseline and at 3,6, 12 and 18 months after initiation of teduglutide treatment | 
| Change From Baseline in PN/IV Caloric Intake | Change from baseline in PN/IV calories intake at 3, 6, 12 and 18 months after teduglutide treatment initiation will be reported. | Baseline and at 3, 6, 12 and 18 months after initiation of teduglutide treatment | 
| Change From Baseline in PN/IV Protein Intake | Change from baseline in PN/IV Protein intake at 3, 6,12 and 18 months after teduglutide treatment initiation will be reported. | Baseline and at 3, 6, 12 and 18 months after initiation of teduglutide treatment | 
| Number of Participants Achieving Response of 20 % 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. | Up to 18 months after teduglutide treatment initiation | 
| Number of Participants Who do Not Require an Intestinal Transplant | Number of participants who no longer require an intestinal transplant after teduglutide treatment initiation will be assessed. | Up to 18 months after teduglutide treatment initiation | 
| Change From Baseline in Body Mass Index (BMI) | Change from baseline in BMI after treatment with teduglutide initiation at 3, 6, 12 and 18 months will be reported. | Baseline and at 3, 6, 12 and 18 months after initiation of teduglutide treatment | 
| Change From Baseline in Stool Frequency Per Day After Initiation of Treatment With Teduglutide | Change in stool frequency per day and at 3, 6, 12 and 18 months after initiation of treatment with teduglutide compared to baseline will be reported. | Baseline and at 3, 6, 12 and 18 months after initiation of teduglutide treatment | 
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values | Number of participants with clinically significant changes from baseline in laboratory values (blood parameters such as serum albumin, creatine, liver enzymes, electrolytes, extended electrolytes) will be reported. | Up to 18 months | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 18 months) | 
| Change From Baseline in Colonoscopic Values | Colonoscopies and associated results at baseline and 1 year after treatment initiation be reported. | Baseline and at 1 year after teduglutide treatment initiation | 
| Weekly Volume of PN/IV Fluid Support After Teduglutide Treatment Discontinuation | Weekly volume of PN/IV Fluid support after teduglutide treatment discontinuation will be reported. | Up to 18 Months | 
| PN/IV Caloric Intake After Teduglutide Treatment Discontinuation | PN/IV caloric intake after teduglutide treatment discontinuation will be reported. | Up to 18 Months |