Trials / Terminated
TerminatedNCT00206700
Open-label Trial of Leukine in Active Crohn's Disease
Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 378 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to establish a safety profile sargramostim administered in 8 week cycles to adult patients with active Crohn's disease.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sargramostim (Leukine) | Open Label, 8 week cycle |
Timeline
- Start date
- 2003-02-01
- Primary completion
- 2006-12-01
- Completion
- 2006-12-01
- First posted
- 2005-09-21
- Last updated
- 2013-12-04
Locations
167 sites across 10 countries: United States, Argentina, Australia, Brazil, Canada, New Zealand, Russia, Switzerland, Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00206700. Inclusion in this directory is not an endorsement.