NCT01560403

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Teduglutide	0.05 mg/kg/day subcutaneously taken once per day for 12 months

Timeline

• Start date: 2012-05-21
• Primary completion: 2013-07-23
• Completion: 2013-07-23
• First posted: 2012-03-22
• Last updated: 2021-06-10
• Results posted: 2014-12-25

Locations

5 sites across 1 country: United States