Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease
NCT ID: NCT00206661
Last Updated: 2013-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
22 participants
INTERVENTIONAL
2004-12-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1
Sargramostim (Leukine)
4 mcg sargramostim with and without corticosteroids
Arm 2
Sargramostim (Leukine)
6 mcg sargramostim with and without corticosteroids
Interventions
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Sargramostim (Leukine)
4 mcg sargramostim with and without corticosteroids
Sargramostim (Leukine)
6 mcg sargramostim with and without corticosteroids
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be able to provide verbal or written assent depending on age
* Age 6 to 16 years
* Have confirmed diagnosis of Crohn's Disease at study time of study entry based on radiologic, endoscopic, or histologic evaluations
* Have a PCDAI score \>/= 30 points
* Have a negative serum pregnancy test within 7 days prior to receiving the first dose of sargramostim in female patients who, in the opinion of the investigator, are sexually active and of childbearing potential
* Be able to self-inject sargramostim or have a designee who can do so
* Available documentations of weight from 4 to 6 months prior to study entry
Exclusion Criteria
* Immediate need of GI surgery for active GI bleeding, peritonitis, intestinal obstruction, or intra-abdominal or perianal abscess requiring surgical drainage
* GI surgery within 3 month prior to receiving the first dose of sargramostim
* Symptoms of bowel obstruction or confirmed evidence of a clinically significant stricture within the last 6 month that has not been surgically corrected
* Use of any of the following medications within 4 weeks prior to receiving the first dose of study drug: 6 mercaptopurine, azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, or thalidomide
* Use of licensed/registered and/or experimental anti-tumor necrosis factor (TNF) therapy such as infliximab or adalimumab within 8 weeks prior to first dose of sargramostim
* Use of any investigational drug within 4 weeks or 5 half-lives (whichever is greater) prior to receiving the first dose of sargramostim
* Concurrent use of corticosteroid therapy for Crohn's Disease, which exceeds a dose of 60 mg/day (or equivalent) of prednisone
* Inability to comply with protocol requirements or provide informed consent
* Presence of clinically important comorbid condition(s) unrelated to Crohn's Disease
* Prior use of recombinant human GM-CSF (sargramostim or molgramostim) or granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim)
* Current use of nutritional therapy (i.e., tube feeding or elemental/polymeric diet) which provides \> 50% of daily caloric intake
6 Years
16 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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San Francisco, California, United States
Atlanta, Georgia, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Morristown, New Jersey, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Countries
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Other Identifiers
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91409
Identifier Type: -
Identifier Source: secondary_id
Novel 6
Identifier Type: -
Identifier Source: secondary_id
308001
Identifier Type: -
Identifier Source: org_study_id