Safety and Efficacy Study in the Treatment of Pediatric Crohn's Disease

Genzyme

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Crohn Disease

Treatments

Drug: Sargramostim (Leukine)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206661

91409

308001

Novel 6

Details and patient eligibility

About

The purpose of this study is to observe pediatric Crohn's Disease response to sargramostim in patients with or without steroid therapy at two possible dosage levels.

Full 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.

Enrollment

22 patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have a parent or guardian able to provide written informed consent
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

Existing colostomy or ileostomy
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