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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: No
View:

• 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.

Locations
Other Locations
Argentina
IC Projects
Recruiting
Buenos Aires
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: November 5, 2020
Estimated Completion Date: November 5, 2022
Participants
Target number of participants: 28
Treatments
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.
Authors
Héctor Manue Solar Muñiz, Martin Balacco, Adriana Fernandez, Raul Bozzo, Maria Ines Martinez, Silvia De Barrio, Martin Buncuga, Veronica Busoni, Alejandra Manzur
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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