A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- Percentage of Participants With Clinical Response at Week 12 and 24 [Week 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 24 [Baseline, 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 24 [Baseline, 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Have received at least one dose of teduglutide according to approved indications.
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Signed the mandatory consent that has been agreed with national regulatory authorities (ANMAT) as applicable.
Exclusion Criteria:
- Not Applicable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IC Projects | Buenos Aires | Argentina | C1055AAD |
Sponsors and Collaborators
- Takeda
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- TAK-633-4003