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NCT05371028 | Recruiting | Short Bowel Syndrome (SBS)

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

Takeda

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.

Condition or disease

Short Bowel Syndrome (SBS)

Intervention/treatment

Non-interventional Study

Study Type : Observational
Estimated Enrollment : 100 participants
Official Title : A Non-interventional, Multicentre Retrospective Study of the Effectiveness and Safety of Teduglutide (REVESTIVE®) in Short Bowel Syndrome Patients in Canada
Actual Study Start Date : September 23, 2023
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : March 31, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
A Study of Teduglutide (Revestive®) in Participants With Short Bowel Syndrome (SBS) in Canada

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

Canada, Ontario

Innomar Strategies

Oakville, Ontario, Canada, L6L 0C4