NCT02980666

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

A 24-week Safety, Efficacy, Pharmacodynamic, and Pharmacokinetic Study of Teduglutide in Japanese Pediatric Subjects, Aged 4 Months Through 15 Years, With Short Bowel Syndrome Who Are Dependent on Parenteral Support

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 4 Months – 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if an investigational treatment (teduglutide) is safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who are dependent on parenteral support. This study will also evaluate how teduglutide moves through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	0.05 mg/kg/day SC injection once daily for 24 weeks.

Timeline

• Start date: 2017-01-13
• Primary completion: 2020-01-21
• Completion: 2020-01-21
• First posted: 2016-12-02
• Last updated: 2022-02-02
• Results posted: 2021-02-10

Locations

5 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study