Status:
COMPLETED
Omalizumab to Treat Eosinophilic Gastroenteritis
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Gastroenteritis
Eligibility:
All Genders
12-76 years
Phase:
PHASE2
Brief Summary
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 dis...
Detailed Description
Eosinophilic gastroenteritis (EG) is characterized by eosinophilic infiltration of the bowel wall, gastrointestinal symptoms, and in more than 50% of patients, peripheral eosinophilia. Approximately o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 2 2004
Trial Type :
INTERVENTIONAL
End Date :
February 5 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00084097
Start Date
June 2 2004
End Date
February 5 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892