Sargramostim (leukine)    (DrugBank: Sargramostim)

1 disease
IDDisease name (Link within this page)Number of trials
96Crohn disease7

96. Crohn disease    [ 2,209 clinical trials,   1,276 drugs,   (DrugBank: 240 drugs),   166 drug target genes,   210 drug target pathways]
Searched query = "Crohn disease", "Terminal ileitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
7 / 2,209 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT00329537
(ClinicalTrials.gov)
June 200623/5/2006Study of Sargramostim in Moderately to Severely Active Crohn's DiseaseOpen-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)Crohn's DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth11Phase 2Japan
2NCT00295165
(ClinicalTrials.gov)
January 200621/2/2006Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseaseRandomized, 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 Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth33Phase 3United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine
3NCT00206661
(ClinicalTrials.gov)
December 200412/9/2005Safety and Efficacy Study in the Treatment of Pediatric Crohn's DiseasePhase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment ExtensionCrohn DiseaseDrug: Sargramostim (Leukine)Genzyme, a Sanofi CompanyNULLTerminated6 Years16 YearsBoth22Phase 1;Phase 2United States
4NCT00206674
(ClinicalTrials.gov)
September 200413/9/2005Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseasePhase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLCompleted18 YearsN/ABoth286Phase 3Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom
5NCT00206713
(ClinicalTrials.gov)
July 200413/9/2005Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With SargramostimPhase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to SargramostimCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth264Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT00206596
(ClinicalTrials.gov)
July 200312/9/2005Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's DiseaseRandomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine);Drug: PlaceboGenzyme, a Sanofi CompanyNULLCompleted18 Years80 YearsBoth127Phase 2United States;Canada
7NCT00206700
(ClinicalTrials.gov)
February 200313/9/2005Open-label Trial of Leukine in Active Crohn's DiseaseOpen-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's DiseaseCrohn DiseaseDrug: Sargramostim (Leukine)Genzyme, a Sanofi CompanyNULLTerminated18 YearsN/ABoth378Phase 2United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom