Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084097
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2004-06-05
Brief Title:
Omalizumab to Treat Eosinophilic Gastroenteritis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of Omalizumab in Eosinophilic Gastroenteritis
Status:
COMPLETED
Status Verified Date:
2008-12-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 subjects 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 subjects 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
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 subjects 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 subjects 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
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 one half of EG patients have multiple food allergies andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-I-0176 | None | None | None |