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.

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.

Inclusion Criteria:

- must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion Criteria:

We found this trial at

sites

Vanderbilt University Medical Center

1211 Medical Center Dr
Nashville, Tennessee 37232

(615) 322-5000