- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00084097
Omalizumab to Treat Eosinophilic Gastroenteritis
Pilot Study of Omalizumab in Eosinophilic Gastroenteritis
This study will evaluate the safety and usefulness of omalizumab (anti-IgE, Xolair) in reducing eosinophil counts and improving symptoms in patients with eosinophilic gastroenteritis (EG). EG is a disorder of unknown cause in which eosinophils, a type of white blood cell, are increased in the blood and gut tissue. Patients with EG have symptoms like stomach pain, bloating, and vomiting. About 50 percent of EG patients have food or environmental allergies, which may play a role in EG. Some patients with EG improve significantly on diets avoiding foods to which they are allergic. Immunoglobulin E (IgE) is an antibody that plays an important role in initiating allergic reactions. Omalizumab is a monoclonal antibody directed against IgE. The Food and Drug Administration approved omalizumab in 2003 for treating patients 12 years of age and older with allergic asthma.
Patients between 12 and 76 years of age with eosinophilic gastroenteritis who have a blood eosinophil count of 500 or more and who have a food allergy or allergy to an inhaled allergen may be eligible for this study. Candidates are screened with a medical history, physical examination, and blood and urine tests.
Participants undergo the following procedures:
- Leukapheresis. This procedure is done to collect quantities of white blood cells to study the effects of omalizumab on eosinophils and other immune substances. Blood flows from a needle placed in an arm vein through a catheter (plastic tube) into a machine that separates the blood into its components by centrifugation (spinning). Some of the white cells are removed and the rest of the blood (red cells, plasma and platelets) is returned to the body through a needle in the other arm.
- Skin testing. Participants are tested for allergies to specific substances. A small amount of various allergens (substances that cause allergies) are placed on the subject's arm. The skin is pricked at the sites of the allergens and the skin reaction after several minutes is observed.
- Upper and lower endoscopy. One or both of these procedures is done, depending on the part of the gastrointestinal tract that is involved, to examine the tract. If both procedures are done, they are performed at the same time. For the upper endoscopy, the subject's throat is sprayed with a numbing medicine and a long, flexible tube is passed through the esophagus, stomach and small intestine. For the lower endoscopy, the tube is passed through the rectum into t...
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
-INCLUSION CRITERIA:
- All Subjects must be at least 12 years of age and no older than 76 years of age.
- All subjects must meet the established diagnostic criteria for eosinophilic gastroenteritis: gastrointestinal symptoms, histologic evidence of gastrointestinal tissue infiltration by eosinophils with greater than or equal to 25 eosinophils per high powered field, no known etiology for the eosinophilia despite careful clinical evaluation.
- Eosinophilia greater than 500/mm3 at screening.
Baseline values within the following laboratory ranges:
- White blood cell count greater than or equal to 3,300 cells/uL
- Absolute neutrophil count greater than or equal to 1,000 cells/uL
- Hemoglobin greater than or equal to 10 g/dL
- Platelet count greater than or equal to 100,000 platelets uL
Evidence of atopy as defined by one of the following:
- Skin testing
- RAST testing
- Serum IgE greater than or equal to100
- Women of childbearing potential only: negative serum Beta-hCG.
- Agree to practice abstinence or effective contraception from initiation of the protocol and for 3 months following the last infusion of the study drug (effective contraception methods include abstinence, surgical sterilization of either partner, barrier methods such as diaphragm, condom, cap, or sponge, or hormonal contraception).
- Weight (Kg) x serum IgE (IU/mL) less than or equal to 63,000 (per dosing restrictions).
- Stable corticosteroid dose for one month prior to screening and willingness to continue on that dose for the first 16 weeks of the study.
- Subjects (guardians for younger patients) must be able to give informed consent (or assent as appropriate).
EXCLUSION CRITERIA:
- Pregnant or nursing women.
- HIV positive or other known immunodeficiency.
- Use of any other investigational agent within 30 days of the study.
- Presence of FIP1-PDGF-R fusion gene.
- Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Evaluation of safety of omalizumab and its efficacy in reducing peripheral blood absolute eosinophil count pre- and post-omalizumab administration.
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Collaborators and Investigators
Publications and helpful links
General Publications
- Lee M, Hodges WG, Huggins TL, Lee EL. Eosinophilic gastroenteritis. South Med J. 1996 Feb;89(2):189-94. doi: 10.1097/00007611-199602000-00006.
- Kelly KJ. Eosinophilic gastroenteritis. J Pediatr Gastroenterol Nutr. 2000;30 Suppl:S28-35. doi: 10.1097/00005176-200001001-00005.
- Park HS, Kim HS, Jang HJ. Eosinophilic gastroenteritis associated with food allergy and bronchial asthma. J Korean Med Sci. 1995 Jun;10(3):216-9. doi: 10.3346/jkms.1995.10.3.216.
- Foster B, Foroughi S, Yin Y, Prussin C. Effect of anti-IgE therapy on food allergen specific T cell responses in eosinophil associated gastrointestinal disorders. Clin Mol Allergy. 2011 Apr 28;9(1):7. doi: 10.1186/1476-7961-9-7.
- Prussin C, Lee J, Foster B. Eosinophilic gastrointestinal disease and peanut allergy are alternatively associated with IL-5+ and IL-5(-) T(H)2 responses. J Allergy Clin Immunol. 2009 Dec;124(6):1326-32.e6. doi: 10.1016/j.jaci.2009.09.048.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Gastrointestinal Diseases
- Hypersensitivity
- Esophageal Diseases
- Esophagitis
- Leukocyte Disorders
- Eosinophilia
- Gastroenteritis
- Eosinophilic Esophagitis
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Omalizumab
Other Study ID Numbers
- 040176
- 04-I-0176
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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