Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | January 2013 |
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.
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.
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.
Inclusion Criteria:
- must have completed 24 weeks of dosing of the CL0600-020 study
Exclusion Criteria:
We found this trial at
7
sites
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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