A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

• Status: Completed
• Trial end date: 2013-07-23
• Target enrollment: 0
• Participant gender: All

Summary

This study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

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

Details

• Lead Sponsor: Shire
• Treatments: Teduglutide

Criteria

Inclusion Criteria:

• At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:

1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support

2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion Criteria:

• None