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

NCT05371028 | Completed

• 2 other identifiers: TAK-633-4006MACS-2020-112501
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Short Bowel Syndrome (SBS)

Outcome Measures

Primary Outcomes (3)

• 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 48 Months

Secondary Outcomes (6)

• 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

• 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

• 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

• 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

• Number of Participants With Reasons of Treatment Interruption and Discontinuation

  From teduglutide treatment initiation up to 48 months

Study Arms (1)

Participants With SBS-IF

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.

Other: Non-interventional Study

Interventions

Non-interventional Study OTHER

This is non-interventional study.

Participants With SBS-IF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Participants with active gastrointestinal malignancy OR a history of gastrointestinal malignancy in the past 5 years before start of treatment.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Innomar Strategies

Oakville, Ontario, L6L 0C4, Canada

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 12, 2022
• Study Start: September 23, 2023
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CA (1)