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)

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.

Study Overview

• Status: Recruiting
• Conditions: Short Bowel Syndrome
• Intervention / Treatment: Drug: Teduglutide

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Takeda Contact; Phone Number: +1-877-825-3327; Email: medinfoUS@takeda.com

Study Locations

• Japan
  • Tokyo, Japan
    • Recruiting
    • Takeda selected site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Teduglutide 0.05 mg/kg SC injection; Other Names: TAK-633; Revestive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support	Changes from baseline in prescription volume of PN/IV support prescribed by investigators to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.	Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline in Prescription Volume of PN/IV Support	Percent change from baseline in prescription volume of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [prescription volume at each timepoint - prescription volume at baseline] / prescription volume at baseline * 100 (percent).	Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Changes from Baseline in Dose of PN/IV Support	Changes from baseline in actual dose of PN/IV support to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported.	Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percent Change from Baseline of Dose in PN/IV Support	Percent change from baseline in actual dose of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; [actual dose at each timepoint - actual dose at baseline] / actual dose at baseline * 100 (percent).	Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Percentage of Participants who Completely Wean off PN/IV Support	Number of participants who completely wean off PN/IV support will be assessed.	Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation
Crohn's Disease Activity Index (CDAI)	CDAI score is calculated from the following 8 items: (a) Number of liquid or very soft stools; (b) Abdominal pain; (c) General wellbeing; (d) Extraintestinal complications; (e) Antidiarrhoeal drugs; (f) Abdominal mass; (g) Hematocrit; and (h) Body weight. Scores of some items in CDAI are calculated based on patient diary. Total range of score is more than 0. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450.	36 months after teduglutide treatment initiation

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Syndrome; Short Bowel Syndrome; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Radiation-Protective Agents; Teduglutide
• Other Study ID Numbers: TAK-633-5001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No