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A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
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.
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 those effects increases the longer people are on PN. Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Scripps Clinic & Research Foundation
La Jolla, California, United States
Mount Sinai Medical Center
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
University of Pennslyvania
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Royal Alexandra Hospital
Edmonton, Alberta, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, Canada
Rigshospitalet
Copenhagen, Denmark
Start Date
September 21, 2009
Primary Completion Date
January 24, 2013
Completion Date
January 24, 2013
Last Updated
June 11, 2021
88
ACTUAL participants
teduglutide
DRUG
Lead Sponsor
Shire
Collaborators
NCT07197944
NCT05561647
NCT06973304
Data Source & Attribution
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