Conditions: Short Bowel Syndrome
Keywords: short bowel syndrome parenteral nutrition PN HPN TPN SBS
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 88
Healthy volunteers: no

Brief 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.

Arms:
arm 1: 0.05 mg/kg/day

Interventions: intervention 1: teduglutide
Intervention descriptions: intervention 1: 0.05 mg/kg/day subcutaneously taken once per day for 24 months

Protocol document: