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

Last updated: July 18, 2023
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Bowel Dysfunction

Treatment

N/A

Clinical Study ID

NCT04877431
TAK-633-4003
  • Ages > 1
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult participants (greater than or equal to [>=] 18 years) or pediatric (>= 1 yearand 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

Exclusion Criteria:

  • Not Applicable.

Study Design

Total Participants: 45
Study Start date:
November 05, 2020
Estimated Completion Date:
June 05, 2023

Connect with a study center

  • IC Projects

    Buenos Aires, C1055AAD
    Argentina

    Site Not Available

  • Fundación Favaloro

    Caba, C1095
    Argentina

    Site Not Available

  • Htal de Niños Santisima Trinidad Cordoba

    Córdoba, X5014AKM
    Argentina

    Site Not Available

  • Hospital Español

    Mendoza, 5501
    Argentina

    Site Not Available

  • Clinica Delta de Rosario

    Santa Fe, S2000
    Argentina

    Site Not Available

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