CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Teduglutide +3 moredrug
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.

Search/NCT03571516
NCT03571516Phase 3Completed
CompareCT.gov

A Randomized, Open-label, 24-Week Safety, Efficacy, and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome Who Are Dependent on Parenteral Support

Shire·interventional·Posted Jun 27, 2018·Updated May 11, 2021

In Brief

A Phase 3 clinical trial evaluating Teduglutide, Standard Medical Therapy, and 2 other interventions for Short Bowel Syndrome. Completed, enrolled 10 participants across 8 sites in 4 countries.

Detailed Summary

The purpose of the study is to evaluate the safety, efficacy/pharmacodynamics (PD) and pharmacokinetics (PK) of teduglutide treatment in infants with short bowel syndrome (SBS) dependent on parenteral (PN) support.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesFinland, France, Italy, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 27, 2018
Enrollment StartAug 31, 2018
Primary CompletionSep 24, 2020
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.0 years ago

Interventions

Teduglutidedrug

SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.

Standard Medical Therapyother

Standard medical therapy will be administered for 24 weeks.

Syringedevice

Teduglutide will be administered using syringe (510k number: K980987).

Needledevice

Teduglutide will be administered using needle (510k number: K021475).