NCT00072839

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

A Pilot Study of the Safety and Efficacy of ALX-0600 in Subjects With Moderately Active Crohn's Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study is twelve weeks in duration and there are eight weeks of once-daily injections into your abdomen or thigh. There are a total of six visits.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	ALX-0600	teduglutide
DRUG	placebo	placebo solution injected subcutaneously
DRUG	teduglutide 0.05	0.05 mg/jg/d subcutaneous daily injection into thigh or abdomen
DRUG	teduglutide 0.2 mg	0.2 mg/kg/d subcutaneously injected into thigh or abdomen
DRUG	Teduglutide 0.05 dose	0.05 mg/kg/d subcutaneous daily injection into thigh or abdomen
DRUG	teduglutide 0.1 mg dose	0.1 mg/kg/d daily subcutaneous injection into thigh or abdomen

Timeline

• Start date: 2003-11-12
• Primary completion: 2005-07-28
• Completion: 2005-07-28
• First posted: 2003-11-13
• Last updated: 2021-05-25

Locations

26 sites across 2 countries: United States, Canada