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 Who Completed Study CL0600-020|
- further study long-term efficacy and safety in subjects who have completed 24-weeks of dosing in Study CL0600-020 [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Long-term safety data and data on PN/IV volume (L/week) will be collected at each study visit. Numbers of subjects who achieve 20, 50, 75 and 100% reduction in PN/IV volume from baseline will be calculated for each visit during this study. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||April 2012|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
0.05 mg/kg/day subcutaneously taken once per day for 24 months
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.
Show 24 Study Locations
|Study Director:||Bo Joelsson, MD, PhD||NPS Pharmaceuticals|