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

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

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 Overview

• Status: Recruiting
• Conditions: Short Bowel Syndrome (SBS)
• Intervention / Treatment: Other: Non-interventional Study

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Canada
  • Ontario
    • Oakville, Ontario, Canada, L6L 0C4
      • Recruiting
      • Innomar Strategies
      • Contact: Site Contact; Phone Number: (647) 917-6615; Email: cpettengell@pentavere.com
      • Principal Investigator: Chris Pettengell, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; This is non-interventional study.

What is the study measuring?

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 48 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 6,12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported.	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.	Up to 48 months after teduglutide treatment initiation
Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume	Percentage of participants achieving 20% to 100% reduction from baseline in weekly PS volume at 6, 12, 24, 36 and 48 months after initiation of treatment with teduglutide will be reported.	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	Change from baseline in number of days per week with PN/IV usage at 6,12, 24, 36 and 48 months after teduglutide treatment initiation will be reported.	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	Number of participants with reasons of treatment interruption and discontinuation will be reported.	From teduglutide treatment initiation up to 48 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 48 months)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome
• Other Study ID Numbers: TAK-633-4006; MACS-2020-112501 (Other Identifier: Takeda)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No