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

NCT00206661 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2013-12-04

No results posted yet for this study

Summary

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.

Conditions

  • Crohn Disease

Interventions

DRUG

Sargramostim (Leukine)

4 mcg sargramostim with and without corticosteroids

DRUG

Sargramostim (Leukine)

6 mcg sargramostim with and without corticosteroids

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00206661 on ClinicalTrials.gov