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A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Who Are 4 Months or Older

Short Bowel Syndrome Clinical Trial

Official title:
A Phase 3, Open-label Safety Study of Teduglutide in Japanese Pediatric Patients With Short Bowel Syndrome Who Are Dependent on Parenteral Support, Aged 4 Months of Corrected Gestational Age or Older, and Requiring the Dosing of 1.25 mg Formulation

Clinical Trial Summary

The main aims of the study are to check for side effects from teduglutide. Participants will receive a daily injection of teduglutide just under the skin (subcutaneous) for 24 weeks. Then they are followed up for another 4 weeks. Participants may be able to repeat this treatment if they meet specific criteria. The study doctors will check for side effects from teduglutide until it becomes commercially available. The maximum duration of treatment is approximately 18 months.

Clinical Trial Description

A study of teduglutide in Japanese children with short bowel syndrome who are 4 months or older. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05027308
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 3
Start date January 4, 2022
Completion date September 27, 2023
View Details
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