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

Short Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877431
• Other study ID #: TAK-633-4003
• Status: Completed
• Start date: November 5, 2020
• Est. completion date: June 5, 2023

Study information

• Verified date: July 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 5, 2023
• Est. primary completion date: June 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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.

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
Argentina	IC Projects	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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