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| Sponsor: | Genzyme |
|---|---|
| Information provided by: | Genzyme |
| 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) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
|---|---|
| Experimental: Arm 1 |
Drug: Sargramostim (Leukine)
Open Label, 8 week cycle
Other Name: BAY86-5326
|
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.
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: | Medical Monitor | Genzyme |
More Information
| Responsible Party: | Medical Monitor, Genzyme |
| ClinicalTrials.gov Identifier: | NCT00206700 History of Changes |
| Obsolete Identifiers: | NCT00185471 |
| Other Study ID Numbers: | 91274, 307340, Novel 5 |
| Study First Received: | September 13, 2005 |
| Last Updated: | July 28, 2010 |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Molgramostim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |