Status:
COMPLETED
Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
Lead Sponsor:
Shire
Collaborating Sponsors:
Nycomed Germany GmbH
Conditions:
Short Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.
Detailed Description
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for tho...
Eligibility Criteria
Inclusion
- must have completed 24 weeks of dosing of the CL0600-020 study
Exclusion
- none
Key Trial Info
Start Date :
September 21 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2013
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00930644
Start Date
September 21 2009
End Date
January 24 2013
Last Update
June 11 2021
Active Locations (23)
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1
Scripps Clinic & Research Foundation
La Jolla, California, United States, 92037
2
Mount Sinai Medical Center
New York, New York, United States, 10029
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
4
University of Pennslyvania
Philadelphia, Pennsylvania, United States, 19104