At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 10 enrolled
Drug / intervention
Teduglutidedrug
Likely dose
Teduglutide 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Teduglutide for Short Bowel Syndrome. Completed, enrolled 10 participants across 5 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionJan 2020
TodayJul 2026
First PostedDec 2, 2016
Enrollment StartJan 13, 2017
Primary CompletionJan 21, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 9.6 years ago
Interventions
Teduglutidedrug
0.05 mg/kg/day SC injection once daily for 24 weeks.