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

Takeda

Status: Completed

Conditions: Short Bowel Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT04877431

TAK-633-4003

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• Not Applicable.

Trial design

45 participants in 2 patient groups

De Nova Participants

Description:

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.

Legacy Participants

Description:

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.