NCT00930644

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Short Bowel Syndrome

Interventions

Type	Name	Description
DRUG	teduglutide	0.05 mg/kg/day subcutaneously taken once per day for 24 months

Timeline

• Start date: 2009-09-21
• Primary completion: 2013-01-24
• Completion: 2013-01-24
• First posted: 2009-06-30
• Last updated: 2021-06-11
• Results posted: 2014-12-24

Locations

23 sites across 9 countries: United States, Canada, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom