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| Sponsor: | Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00206700 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn Disease |
Drug: Sargramostim (Leukine, BAY86-5326) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Open-Label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease |
| Enrollment: | 378 |
| Study Start Date: | February 2003 |
| Study Completion Date: | December 2006 |
| Arms | Assigned Interventions |
|---|---|
| Arm 1: Experimental |
Drug: Sargramostim (Leukine, BAY86-5326)
Open Label, 8 week cycle
|
This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 167 Study Locations| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head ) |
| Study ID Numbers: | 91274, 307340, Novel 5 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00206700 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
|
Digestive System Diseases Antineoplastic Agents Gastrointestinal Diseases Therapeutic Uses Crohn Disease |
Inflammatory Bowel Diseases Molgramostim Intestinal Diseases Gastroenteritis Pharmacologic Actions |