A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-05

Study Completion Date

2023-06-05

Brief Summary

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The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

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Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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De Nova Participants

De nova participants who had received teduglutide after marketing authorization will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up.

No interventions assigned to this group

Legacy Participants

Legacy participants who received teduglutide treatment prior to marketing authorization under expanded access type of program will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult participants (greater than or equal to \[\>=\] 18 years) or pediatric (\>= 1 year and less than \[\<\] 18) with a diagnosis of SBS who are dependent on parenteral support.
* Have received at least one dose of teduglutide according to approved indications.
* Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.