Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
|ClinicalTrials.gov Identifier: NCT00930644|
Recruitment Status : Completed
First Posted : June 30, 2009
Results First Posted : December 24, 2014
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Drug: teduglutide||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||88 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
0.05 mg/kg/day subcutaneously taken once per day for 24 months
Other Name: Gattex
- Percent Change in PN/IV Volume by Visit [ Time Frame: 24 months ]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 ]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 ]The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930644
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|Study Director:||NPS Clinical Trials||NPS Pharma|