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

Completed
Conditions
Short Bowel Syndrome
Registration Number
NCT04877431
Lead Sponsor
Takeda
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
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.
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Exclusion Criteria
  • Not Applicable.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse Events of Special Interest (AESI)Up to 24 months

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).

Number of Participants With Adverse Events (AEs)Up to 24 months

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.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants With Clinical Response at Week 12 and 24Week 12 and 24

Clinical response will be defined as a 20 percent (%) or more reductions on weekly parenteral support volume.

Change From Baseline in Weekly Parenteral Support Volume at Week 12 and 24Baseline, Week 12 and 24

Parenteral support volume will be assessed at baseline (before treatment), and at Week 12, and 24.

Change From Baseline in Number of Days per Week of Parenteral Support at Week 12 and 24Baseline, 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.

Trial Locations

Locations (1)

IC Projects

🇦🇷

Buenos Aires, Argentina

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