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

Short Bowel Syndrome (SBS) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05371028
• Other study ID #: TAK-633-4006
• Secondary ID: MACS-2020-112501
• Status: Recruiting
• Start date: September 23, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Short Bowel Syndrome (SBS)
• Syndrome

Intervention

Other:
• Non-interventional Study
This is non-interventional study.

Locations

Country	Name	City	State
Canada	Innomar Strategies	Oakville	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)

External Links

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