Status:

COMPLETED

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

Lead Sponsor:

Takeda

Conditions:

Short Bowel Syndrome

Eligibility:

All Genders

1+ years

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 (Revesti...

Eligibility Criteria

Inclusion

  • 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

  • \- Not Applicable.

Key Trial Info

Start Date :

November 5 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 5 2023

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT04877431

Start Date

November 5 2020

End Date

June 5 2023

Last Update

July 19 2023

Active Locations (1)

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IC Projects

Buenos Aires, Argentina, C1055AAD

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