At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3 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 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
In Brief
A Phase 3 clinical trial evaluating Teduglutide for Short Bowel Syndrome. Completed, enrolled 3 participants across 6 sites.
Detailed 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 51.3 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartJan 2022
Primary CompletionSep 2023
TodayJul 2026
First PostedAug 30, 2021
Enrollment StartJan 4, 2022
Primary CompletionSep 27, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 4.8 years ago
Interventions
Teduglutidedrug
Teduglutide 0.05 mg/kg SC injection