Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome|
- Percent Change in PN/IV Volume by Visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
- Absolute Change in PN/IV Volume by Visit [ Time Frame: 24 months ] [ Designated as safety issue: No ]The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
- Number of Subjects Achieving PN/IV Reduction [ Time Frame: 24 Months or Last Dosing Visit ] [ Designated as safety issue: No ]The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
|Study Start Date:||September 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Other Name: Gattex
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930644
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|Study Director:||NPS Clinical Trials||NPS Pharma|