A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease

Post Authorization Study to Monitor Efficacy, Effectiveness and Safety of Teduglutide (Revestive®) in Adult and Pediatric Patients With Short Bowel Syndrome in Argentina

The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).

This study is about collecting data only; participants receive Teduglutide (Revestive®) by their doctors according to the clinical practice but not as part of this study. Only standard care information available in the participant's medical records will be reviewed and collected for this study.

Participants do not need to visit their doctor in addition to their normal visits.

Study Overview

• Status: Completed
• Conditions: Short Bowel Syndrome

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1055AAD
    • IC Projects

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All adult and pediatric participants who are treated with teduglutide according to approved indications.

Description

Inclusion Criteria:

• Adult participants (greater than or equal to [>=] 18 years) or pediatric (>= 1 year and less than [<] 18) with a diagnosis of SBS who are dependent on parenteral support.
• Have received at least one dose of teduglutide according to approved indications.
• Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.

Exclusion Criteria:

- Not Applicable.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
De Nova Participants; De nova participants who had received teduglutide after marketing authorization will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up.
Legacy Participants; Legacy participants who received teduglutide treatment prior to marketing authorization under expanded access type of program will be enrolled in this study and monitored by their physicians according to local clinical practice then followed for 24-weeks unless treatment discontinuation or lost to follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events of Special Interest (AESI)	AESI will include biliary disorders and cholecystitis; pancreatic disease; cardiovascular adverse events associated with fluid overload; intestinal obstruction; stoma complications; malignancy; gastrointestinal neoplastic growth, including colorectal polys and small bowel neoplasia; adverse events associated with increased absorption of concomitant oral medications; anxiety; injection site reactions and suspected immunogenic reactions (like hypersensitivity or other reactions); embryo-fetal toxicity (assessed through follow up of all pregnancies).	Up to 24 months
Number of Participants With Adverse Events (AEs)	An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse events (SAEs) is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, congenital abnormality/birth defect, an important medical event. Number of participants with AEs including serious and non-serious AEs will be assessed.	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at Week 12 and 24	Clinical response will be defined as a 20 percent (%) or more reductions on weekly parenteral support volume.	Week 12 and 24
Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24	Parenteral support volume will be assessed at baseline (before treatment), and at Week 12, and 24.	Baseline, Week 12 and 24
Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24	Change from baseline in number of days per week requiring parenteral support will be assessed at baseline (before treatment), and at Week 12 and 24.	Baseline, Week 12 and 24

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): June 5, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 18, 2023
• Last Verified: July 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
• Other Study ID Numbers: TAK-633-4003

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