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NCT Number: NCT05371028

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

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Key information

Conditions

Short Bowel Syndrome (SBS) Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Short Bowel Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Innomar Strategies

Oakville, Ontario, L6L 0C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-Interventional Study

Other

This is non-interventional study.

Primary outcomes

  1. Change From Baseline in Weekly Volume of Parenteral Nutrition (PN)/Intravenous (IV) Fluid Requirement at Week 24

    Time frame: Baseline and 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.

  2. Average Change in Number of Days per Week With PN/IV Usage

    Time frame: 6 months before teduglutide treatment initiation and 6 months after teduglutide treatment initiation (approximately 12 months

    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.

  3. Percentage of Participants Achieving PN/IV Independence During the Study Period

    Time frame: Up to 48 Months

    Percentage of participants who will achieve PN/IV independence during the study period will be reported.

Secondary outcomes

  1. Change From Baseline in Weekly Volume of PN/IV Fluid Requirement

    Time frame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment

    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.

  2. Number of Participants Achieving Response of 20 percent (%) to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume

    Time frame: Up to 48 months after teduglutide treatment initiation

    Number of participants achieving response of 20% to 100% reduction from baseline in weekly PS volume will be reported.

  3. Percentage of Participants Achieving 20 % to 100% Reduction From Baseline in Weekly Parenteral Support (PS) Volume

    Time frame: Baseline and at 6, 12, 24, 36 and 48 months after initiation of teduglutide treatment

    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.

  4. Change From Baseline in Number of Days per Week With PN/IV Usage

    Time frame: 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 at 6,12, 24, 36 and 48 months after teduglutide treatment initiation will be reported.

  5. Number of Participants With Reasons of Treatment Interruption and Discontinuation

    Time frame: From teduglutide treatment initiation up to 48 months

    Number of participants with reasons of treatment interruption and discontinuation will be reported.

  6. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: From treatment initiation up to 6 months after teduglutide treatment discontinuation (approximately 48 months)

    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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 12, 2022
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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