A Study of Teduglutide in Japanese People With Short Bowel Syndrome

NCT ID: NCT05023382

Last Updated: 2025-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Short Bowel Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Teduglutide 0.05 milligram per kilogram (mg/kg)

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

Teduglutide

Intervention Type DRUG

Teduglutide 0.05 mg/kg SC injection

Interventions

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Teduglutide

Teduglutide 0.05 mg/kg SC injection

Intervention Type DRUG

Other Intervention Names

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TAK-633 Revestive

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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Takeda Selected Site

Tokyo, Tokyo, Japan

Site Status NOT_YET_RECRUITING

Takeda selected site

Tokyo, Tokyo, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Takeda Contact

Role: CONTACT

+1-877-825-3327

Facility Contacts

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Takeda Site

Role: primary

Site

Role: backup

Related Links

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https://clinicaltrials.takeda.com/study-detail/612d4d9dc61629002b6311cb

To obtain more information on the study, click here/on this link

Other Identifiers

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TAK-633-5001

Identifier Type: -

Identifier Source: org_study_id

jRCT2031210284

Identifier Type: REGISTRY

Identifier Source: secondary_id

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