Pilot Study of Omalizumab in Eosinophilic Gastroenteritis
Data Collection
Digestive System Diseases+9
+ Eosinophilia
+ Esophageal Diseases
Treatment Study
Summary
Study start date: June 2, 2004
Actual date on which the first participant was enrolled.Eosinophilic gastroenteritis (EG) is characterized by eosinophilic infiltration of the bowel wall, gastrointestinal symptoms, and in more than 50% of patients, peripheral eosinophilia. Approximately one half of EG patients have multiple food allergies and/or elevated immunoglobulin E (IgE), suggesting an allergic etiology. The purpose of this study is to evaluate the safety and efficacy of humanized monoclonal anti-IgE antibody, omalizumab (Xolair (Registered Trademark)), in eosinophilic gastroenteritis. Omalizumab is approved for use in asthma and is dosed subcutaneously based on serum total IgE level and body weight, with a maximum dose of 375 mg every 2 weeks. Subjects with EG, and either food hypersensitivity or environmental allergies will be admitted to the Clinical Center. All subjects will undergo a thorough clinical evaluation, including endoscopy. The primary endpoints will be the evaluation of safety of omalizumab and its efficacy in reducing peripheral blood absolute eosinophil count. In addition, the following secondary endpoints will be studied: symptom scores, study drug pharmacodynamics, and tissue eosinophilia. Blood cells and serum will be collected and evaluated in the laboratory to address issues related to the immunopathogenesis and treatment of EG. This study will provide a better understanding of inflammatory and allergy mediators in the pathogenesis of EG and may provide a potential therapy for EG. Following subcutaneous administration of the initial dose of omalizumab (maximum 375 mg), subjects will be followed as inpatients for a minimum of 24 hours to monitor for adverse effects. Subsequent doses will be administered biweekly for a total of 8 doses.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 76 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
-INCLUSION CRITERIA: 1. All Subjects must be at least 12 years of age and no older than 76 years of age. 2. 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. 3. Eosinophilia greater than 500/mm3 at screening. 4. 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 5. Evidence of atopy as defined by one of the following: * Skin testing * RAST testing * Serum IgE greater than or equal to100 6. Women of childbearing potential only: negative serum Beta-hCG. 7. 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). 8. Weight (Kg) x serum IgE (IU/mL) less than or equal to 63,000 (per dosing restrictions). 9. Stable corticosteroid dose for one month prior to screening and willingness to continue on that dose for the first 16 weeks of the study. 10. Subjects (guardians for younger patients) must be able to give informed consent (or assent as appropriate). EXCLUSION CRITERIA: 1. Pregnant or nursing women. 2. HIV positive or other known immunodeficiency. 3. Use of any other investigational agent within 30 days of the study. 4. Presence of FIP1-PDGF-R fusion gene. 5. Any condition that, in the investigator's opinion, places the patient at undue risk by participating in the study.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location