Clinical trial

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

Name

TAK-633-5001

Description

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.

Trial arms

Trial start

2021-09-01

Estimated PCD

2030-07-31

Trial end

2030-07-31

Status

Recruiting

Treatment

Teduglutide

Teduglutide 0.05 mg/kg SC injection

Arms:

Teduglutide 0.05 milligram per kilogram (mg/kg)

Other names:

TAK-633, Revestive

Size

120

Primary endpoint

Number of Participants with Adverse Events

Up to 36 months

Number of Participants with Serious Adverse Events

Up to 36 months

Eligibility criteria

Inclusion Criteria: * All participants in Japan who received teduglutide will be enrolled in this post marketing surveillance. Exclusion Criteria: * None

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2023-10-18

1 organization

1 product

1 indication

Organization

Takeda

Product

Teduglutide

Indication

Short Bowel Syndrome