NCT00206661

Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in patients with or without steroid therapy at two possible dosage levels.

Detailed description

On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
DRUG	Sargramostim (Leukine)	4 mcg sargramostim with and without corticosteroids
DRUG	Sargramostim (Leukine)	6 mcg sargramostim with and without corticosteroids

Timeline

• Start date: 2004-12-01
• Primary completion: 2006-12-01
• Completion: 2006-12-01
• First posted: 2005-09-21
• Last updated: 2013-12-04

Locations

7 sites across 1 country: United States