96. Crohn disease Clinical trials / Disease details

Clinical trials : 2,400 / Drugs : 1,391 - (DrugBank : 267) / Drug target genes : 170 - Drug target pathways : 215

7 trials found

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT00329537 (ClinicalTrials.gov)	June 2006	23/5/2006	Study of Sargramostim in Moderately to Severely Active Crohn's Disease	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)	Crohn's Disease	Drug: Sargramostim (Leukine);Drug: Placebo	Genzyme, a Sanofi Company	NULL	Terminated	18 Years	N/A	Both	11	Phase 2	Japan
2	NCT00295165 (ClinicalTrials.gov)	January 2006	21/2/2006	Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease	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 Crohn's Disease	Crohn Disease	Drug: Sargramostim (Leukine);Drug: Placebo	Genzyme, a Sanofi Company	NULL	Terminated	18 Years	N/A	Both	33	Phase 3	United States;Australia;Brazil;Bulgaria;Canada;Israel;New Zealand;Romania;Russian Federation;South Africa;Ukraine
3	NCT00206661 (ClinicalTrials.gov)	December 2004	12/9/2005	Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease	Phase 1/2 Safety, Pharmacokinetic, and Pharmacodynamic Study of Sargramostim (Leukine®) in Pediatric Patients With Active Crohn's Disease, With One-year Surveillance and Retreatment Extension	Crohn Disease	Drug: Sargramostim (Leukine)	Genzyme, a Sanofi Company	NULL	Terminated	6 Years	16 Years	Both	22	Phase 1/Phase 2	United States
4	NCT00206674 (ClinicalTrials.gov)	September 2004	13/9/2005	Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's Disease	Phase 3 Randomized, Double-Blind, Placebo Controlled Induction Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease	Crohn Disease	Drug: Sargramostim (Leukine);Drug: Placebo	Genzyme, a Sanofi Company	NULL	Completed	18 Years	N/A	Both	286	Phase 3	Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom
5	NCT00206713 (ClinicalTrials.gov)	July 2004	13/9/2005	Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn's Disease Who Have Previously Responded to Treatment With Sargramostim	Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Retreatment Study of Sargramostim (Leukine®) in Patients With Active Crohn's Disease and Prior Treatment Response to Sargramostim	Crohn Disease	Drug: Sargramostim (Leukine);Drug: Placebo	Genzyme, a Sanofi Company	NULL	Terminated	18 Years	N/A	Both	264	Phase 3	United States
6	NCT00206596 (ClinicalTrials.gov)	July 2003	12/9/2005	Study in Patients With Crohn's Disease Who Are Steroid Dependent, Despite Previous Unsuccessful Attempts to Reduce Steroids Due to Worsening of Crohn's Disease	Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease	Crohn Disease	Drug: Sargramostim (Leukine);Drug: Placebo	Genzyme, a Sanofi Company	NULL	Completed	18 Years	80 Years	Both	127	Phase 2	United States;Canada
7	NCT00206700 (ClinicalTrials.gov)	February 2003	13/9/2005	Open-label Trial of Leukine in Active Crohn's Disease	Open-label Trial of Leukine® (Sargramostim), A Recombinant Human Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF), in Active Crohn's Disease	Crohn Disease	Drug: Sargramostim (Leukine)	Genzyme, a Sanofi Company	NULL	Terminated	18 Years	N/A	Both	378	Phase 2	United States;Argentina;Australia;Brazil;Canada;New Zealand;Russian Federation;Switzerland;Ukraine;United Kingdom