Trials / Terminated
TerminatedNCT00295165
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Induction Study to Assess the Efficacy and Safety of 6µg Sargramostim (Leukine) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 33 (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 if Leukine can induce clinical response or remission in patients with 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) | Sargramostim 6 mcg/kg subcutaneously once daily |
| DRUG | Placebo | Placebo subcutaneously once daily |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2006-10-01
- Completion
- 2006-10-01
- First posted
- 2006-02-23
- Last updated
- 2013-12-04
Locations
111 sites across 11 countries: United States, Australia, Brazil, Bulgaria, Canada, Israel, New Zealand, Romania, Russia, South Africa, Ukraine
Source: ClinicalTrials.gov record NCT00295165. Inclusion in this directory is not an endorsement.