Trials / Terminated
TerminatedNCT00206713
Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim
Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 264 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether treatment with Leukine in patients with Crohn's disease who have previously responded to Leukine can be helped again, once they have relapsed.
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) | 6 μg/kg sargramostim administered SC once daily for 8 weeks |
| DRUG | Placebo | Placebo administered SC once daily during the randomized retreatment phase. |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2006-10-01
- Completion
- 2006-10-01
- First posted
- 2005-09-21
- Last updated
- 2013-12-04
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00206713. Inclusion in this directory is not an endorsement.