A Study of Teduglutide in Japanese People With Short Bowel Syndrome

Takeda

Status: Enrolling

Conditions: Short Bowel Syndrome

Treatments: Drug: Teduglutide

Study type: Observational

Funder types: Industry

Identifiers

NCT05023382

jRCT2031210284 (Registry Identifier)

TAK-633-5001

Details and patient eligibility

About

The main aims of this study are to check for side effects from treatment with teduglutide (Revestive) and how well teduglutide controls symptoms of short bowel syndrome.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with short bowel syndrome will receive an injection of teduglutide just under the skin (subcutaneous) according to their clinic's standard practice. The study doctors will check for side effects from teduglutide for 36 months.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance.

Exclusion criteria

• None

Trial design

120 participants in 1 patient group

Teduglutide 0.05 milligram per kilogram (mg/kg)

Description:

Participants will receive Teduglutide 0.05 milligram per kilogram (mg/kg) subcutaneous (SC) injection once daily.

Treatment:

Drug: Teduglutide