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

Completed · Phase 3

Conditions studied: Short Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT01560403

Run by

Shire

People needed

14

Starts

2012-05-21

Expected to finish

2013-07-23

Last updated by the study team

2021-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:
• Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
• Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

You may not qualify if…

• None

Where it is running

• Scripps Clinic & Research Foundation — La Jolla, California, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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