Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329537
Status:
TERMINATED
Last Update Posted:
2013-12-04
First Post:
2006-05-23
Brief Title:
Study of Sargramostim in Moderately to Severely Active Crohns Disease
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Open-Label Phase 1 Study to Assess the Tolerability Pharmacokinetics and Safety of 2 and 6 µgkg Sargramostim SH L 04023 Administered Subcutaneously Once Daily for 4 Weeks and Randomized Double-Blind Placebo-Controlled Phase 2 Study to Assess the Efficacy and Safety of 6 µgkg Sargramostim SH L 04023 Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohns Disease Sargramostim Phase 12 Study
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 assess the tolerability pharmacokinetics and safety of 2 and 6 micro gkgday sargramostim administered subcutaneously once daily for 4 weeks and to assess the efficacy and safety of 6 micro gkgday sargramostim administered subcutaneously once daily for 8 weeks in comparison with placebo in patients with moderately to severely active 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 |
|---|---|---|---|
| 91510 | None | None | None |