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

Takeda

Status: Completed

Conditions: Short Bowel Syndrome (SBS)

Treatments: Other: Non-interventional Study

Study type: Observational

Funder types: Industry

Identifiers

NCT05371028

TAK-633-4006

MACS-2020-112501 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

52 participants in 1 patient group

Participants With SBS-IF

Description:

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.

Treatment:

Other: Non-interventional Study