CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14 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.

Search/NCT01560403
NCT01560403Phase 3Completed
CompareCT.gov

A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021

Shire·interventional·Posted Mar 22, 2012·Updated Jun 10, 2021

In Brief

A Phase 3 clinical trial evaluating Teduglutide for Short Bowel Syndrome. Completed, enrolled 14 participants across 5 sites.

Detailed Summary

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2012
Enrollment StartMay 21, 2012
Primary CompletionJul 23, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.3 years ago

Interventions

Teduglutidedrug

0.05 mg/kg/day subcutaneously taken once per day for 12 months