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

Shire

Status and phase: Completed; Phase 3

Conditions: Short Bowel Syndrome

Treatments: Drug: teduglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00930644

2009-011679-65 (EudraCT Number)

CL0600-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion criteria

• none

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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88 participants in 1 patient group

teduglutide

Experimental group

Description:

0.05 mg/kg/day

Treatment:

Drug: teduglutide