Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295165
Status:
TERMINATED
Last Update Posted:
2013-12-04
First Post:
2006-02-21
Brief Title:
Efficacy Induction of ResponseRemission and Safety Study in Patients With Moderate to Severe Crohns Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
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 Crohns Disease
Status:
TERMINATED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if Leukine can induce clinical response or remission in patients with Crohns 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 91494 | None | None | None |
| NOVEL8 | None | None | None |