A Study With Teduglutide (Revestive®) in Adults With Short Bowl Syndrome (T-Rex)

Takeda

Status: Completed

Conditions: Short Bowel Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT04883606

MACS-2020-04220 (Other Identifier)

TAK-633-4002

Details and patient eligibility

About

The main aims of the study are to assess the safety profile of teduglutide (Revestive®) as well as how many people with Short Bowl Syndrome experience a reduction of parenteral support when treated with teduglutide (Revestive®).

This study is about collecting existing data only; participants will not receive teduglutide (Revestive®) as part of this study. No new information will be collected during this study. Only data already available in the hospital records will be reviewed and collected for this study.

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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants >= 18 years of age diagnosed with intestinal failure due to SBS as a result of intestinal resection.
• SBS-IF participants treated with teduglutide according to Summary of Product Characteristics (SmPC).
• Patients who receive or have received teduglutide for at least six months at the date of inclusion (from treatment initiation to inclusion date, date of discontinuation, death for any cause or loss of follow-up).
• When required by the ethics committee of the center: participants who have signed the informed consent form (ICF) to participate in the study.

Exclusion criteria

• Participants who do not meet the inclusion criteria.

Trial design

65 participants in 1 patient group

All Participants

Description:

Retrospective data will be collected from participants who followed up at least 6 months before teduglutide initiation or intestinal failure associated with SBS-IF diagnosis and at least 6 months of follow-up after teduglutide treatment initiation.