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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
88
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Scripps Clinic & Research Foundation
La Jolla, California, United States
Percent Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Time frame: 24 months
Absolute Change in PN/IV Volume by Visit
The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Time frame: 24 months
Number of Subjects Achieving PN/IV Reduction
The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Time frame: 24 Months or Last Dosing Visit
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