Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease Who Completed Protocol CL0600-008

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether an investigational compound, ALX-0600, is safe and effective in treating Crohn's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Teduglutide

Criteria

Inclusion Criteria:

• Subjects must have completed participation in the Pilot Active Crohn's Disease Study.

• Subjects must continue to meet all inclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

• CDAI score greater than 220

• Stool samples not required

• C-reactive protein levels are not an exclusion criterion

Exclusion Criteria:

• Subject must continue to meet all exclusion criteria for Pilot Active Crohn's Disease Study with the following exceptions:

• Participation in a clinical study of an experimental drug or device within 30 days before signing consent.