Clinical trial NCT05371028: A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada
Official title: A Non-interventional, Multicentre Retrospective Study of the Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Short Bowel Syndrome (SBS)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with SBS-IF, who were treated with teduglutide (Revestive®) in Canada will be observed in this study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24
timeFrame: Baseline and at Week 24
measure: Average Change in Number of Days per Week With PN/IV Usage
timeFrame: 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months
measure: Percentage of Participants Achieving PN/IV Independence During the Study Period
timeFrame: Up to 48 Months
Secondary outcomes:
measure: Change From Baseline in Weekly Volume of PN/IV Fluid Requirement
timeFrame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
measure: Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume
timeFrame: Up to 48 months after teduglutide treatment initiation
measure: Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume
timeFrame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
measure: Change From Baseline in Number of Days per Week With PN/IV Usage
timeFrame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment
measure: Number of Participants With Reasons of Treatment Interruption and Discontinuation
timeFrame: From teduglutide treatment initiation up to 48 months
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 48 months)
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: Innomar Strategies
state: Ontario
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: