Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

• Status: Completed
• Trial end date: 2008-01-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Teduglutide

Criteria

Inclusion Criteria:

At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study.

Subjects who meet all of the following criteria can be enrolled in this study:

• Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed

• Completion of protocol CL0600-004 (NCT00081458)

Exclusion Criteria:

• History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state

• History of alcohol or drug abuse (within previous year)

• Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit

• Pregnant or lactating women

• Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results