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Clinical trial

Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg 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 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)

NCT00329537 is registered in ClinicalTrials.gov with Genzyme, a Sanofi Company as lead sponsor.

NCT NCT00329537
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Registry record

As filed in ClinicalTrials.gov.

Title
Open-Label Phase 1 Study to Assess the Tolerability, Pharmacokinetics and Safety of 2 and 6 µg/kg 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 µg/kg Sargramostim (SH L 04023) Administered Subcutaneously Once Daily for 8 Weeks in Patients With Active Crohn's Disease (Sargramostim Phase 1/2 Study)
Lead sponsor
Genzyme, a Sanofi Company
Phase
Phase 2
Overall status
Terminated
Start date
June 30, 2006
Completion date
May 31, 2007
Enrollment
11 (actual)
Sites
Not reported

Conditions

As the registry lists them; a condition with its own page is linked.

crohn's disease