Status:
COMPLETED
A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Esophagitis
Eligibility:
All Genders
12-60 years
Phase:
PHASE2
Brief Summary
Eosinophilic esophagitis (EE) is an increasingly recognized condition characterized by dysphagia, food impaction or other obstructive esophageal symptoms in children and young adults. The pathophysio...
Detailed Description
This is a dual-center double-blind, placebo controlled trial of omalizumab for the treatment of EE. Omalizumab will be dosed depending on the patient's body weight and baseline IgE level. Omalizumab o...
Eligibility Criteria
Inclusion
- Male or female subjects aged 12-60 years of age with EE as defined above
- Serum IgE level 30-700 IU/mL
- Subjects with acceptable medical history, physical exam and laboratory test results
- No history of bleeding diathesis, significant cardiopulmonary disease, or other contraindication to upper endoscopy
Exclusion
- Need for esophageal dilation at enrollment due to food impaction or inability to pass endoscope
- Inability of subject to provide informed consent (if ages 18-60), or inability of children (ages 12-17) to provide assent
- History of esophagogastric surgery
- Presence of other esophageal pathology that could account for patients' symptoms including eosinophil infiltration due to gastroesophageal reflux disease (GERD)
- Incarceration
- Pregnancy
- Women of childbearing potential not using the contraception method(s)
- Patients with elevated serum IgE levels for reasons other than atopy
- Patients taking cromolyn sodium or nedocromil sodium within 1 month of visit 1
- Patients taking oral or topical corticosteroids within one month of visit 1
- Patients taking leukotriene receptor inhibitors within one month of visit 1
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Patients with a history of noncompliance to medical regimens or who were considered potentially unreliable
- Use of any other investigational agent in the last 30 days
- Patients with a known hypersensitivity to any ingredient of rhuMAb-E25, study rescue medication
- Patients with Barrett's esophagus will be excluded if found endoscopically or pathologically at biopsy
- Currently treated with omalizumab or treated with omalizumab within the past 6 months.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00123630
Start Date
November 1 2005
End Date
January 1 2010
Last Update
May 20 2016
Active Locations (1)
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1
University of Utah HSC
Salt Lake City, Utah, United States, 84132