RecruitingNCT05023382

A Study of Teduglutide in Japanese People With Short Bowel Syndrome

Special Drug Use Investigation of Revestive Subcutaneous Injection 3.8 mg (All-case Surveillance)


Sponsor

Takeda

Enrollment

120 participants

Start Date

Sep 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria1

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

Exclusion Criteria1

  • None

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Interventions

DRUGTeduglutide

Teduglutide 0.05 mg/kg SC injection


Locations(2)

Takeda Selected Site

Tokyo, Tokyo, Japan

Takeda selected site

Tokyo, Tokyo, Japan

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NCT05023382


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