A Study of Teduglutide in Japanese People With Short Bowel Syndrome

NCT05023382 | Active Not Recruiting

• 2 other identifiers: TAK-633-5001jRCT2031210284
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse Events

  An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

  Up to 36 months

• Number of Participants with Serious Adverse Events

  A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability /incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.

  Up to 36 months

Secondary Outcomes (6)

• Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support

  Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation

• Percent Change from Baseline in Prescription Volume of PN/IV Support

  Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation

• Changes from Baseline in Dose of PN/IV Support

  Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation

• Percent Change from Baseline of Dose in PN/IV Support

  Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation

• Percentage of Participants who Completely Wean off PN/IV Support

  Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation

Study Arms (1)

Teduglutide 0.05 milligram per kilogram (mg/kg)

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

Drug: Teduglutide

Interventions

Teduglutide DRUG

Teduglutide 0.05 mg/kg SC injection

Also known as: TAK-633, Revestive

Teduglutide 0.05 milligram per kilogram (mg/kg)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Publications (1)

• Wada M, Nakamura S, Hayashi A, Otake R, Miyamoto M, Tanaka T. Six-Month Safety and Effectiveness of Teduglutide in Patients with Short Bowel Syndrome in Japan: Interim Analysis of Post-marketing Surveillance. Adv Ther. 2026 Jan;43(1):425-441. doi: 10.1007/s12325-025-03398-y. Epub 2025 Dec 1.

  PMID: 41324792 DERIVED

Related Links

• Description: Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
• Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

teduglutide

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 26, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)