Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461097
Status:
COMPLETED
Last Update Posted:
2017-12-13
First Post:
2007-04-16
Brief Title:
Oral Immunotherapy for Childhood Egg Allergy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Oral Desensitization to Egg With Subsequent Induction of Tolerance for Egg-Allergic Children CoFAR 3
Status:
COMPLETED
Status Verified Date:
2017-11
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:
The purpose of this study is to determine if oral immunotherapy OIT will desensitize a child with an allergy to egg and eventually lead to the development of tolerance to egg
Detailed Description:
In the United States as many as 6 to 8 of children are affected by food allergy In young children allergic reactions to egg can range from mild rash to systemic anaphylaxis The usual standard of care for allergy is complete avoidance of this food allergen and treatment of accidental systemic reactions by access to self-injected epinephrine However accidental exposure to allergens in processed foods may be difficult to avoid Currently several therapeutic strategies are being investigated to prevent and treat food allergies Since standard injection under the skin immunotherapy for food allergy is associated with a high rate of allergic reactions a few studies have recently tried oral immunotherapy OIT in food allergy The purpose of this study is to determine the safety and efficacy of the administration of OIT The intent is to develop desensitization and eventually tolerance to egg allergen This study will evaluate tolerance to egg white solid that may be gained by gradually increasing the amounts of egg white solid given to a child over a long period of time
This study will last up to 48 months The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo This study will include dose escalation and maintenance followed by oral food challenge OFC
For participants receiving egg OIT visit 1 consists of multiple small incremental doses of egg white solid This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks At approximately Week 44 participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals Participants and study staff are unblinded following this initial OFC Maintenance egg OIT therapy is continued for an additional 1-3 years Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points approximately Week 96 and annually thereafter to test for desensitization If passed a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg
Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks They are unblinded at that time continue on an egg-restricted diet and are followed until up to 2 years These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E IgE declines to be less than 2 kilounits of antibody per liter this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg
At selected visits blood and urine collection physical examination prick skin tests and atopic dermatitis and asthma evaluations will occur
This study will last up to 48 months The participants will be randomly assigned to receive oral immunotherapy treatment with egg white solid or placebo This study will include dose escalation and maintenance followed by oral food challenge OFC
For participants receiving egg OIT visit 1 consists of multiple small incremental doses of egg white solid This is followed by 32-40 weeks of gradual dose escalation to a stable maintenance dose of egg white solid for at least 8 weeks At approximately Week 44 participants are given an OFC using 5 grams of egg white solid to identify desensitized individuals Participants and study staff are unblinded following this initial OFC Maintenance egg OIT therapy is continued for an additional 1-3 years Oral Food Challenges with 10 grams of egg white solid will be performed for participants on maintenance egg OIT at subsequent time points approximately Week 96 and annually thereafter to test for desensitization If passed a repeat OFC after being off therapy for 4-6 weeks will be performed to test for tolerance An OFC to test for tolerance will use 10 grams of egg white solid and be followed by an open feeding of egg
Participants receiving placebo during dose escalation and maintenance are given an OFC using 5 grams of egg white solid to test for desensitization at approximately 44 weeks They are unblinded at that time continue on an egg-restricted diet and are followed until up to 2 years These participants will only receive an OFC at a subsequent time point if their egg Immunoglobulin E IgE declines to be less than 2 kilounits of antibody per liter this OFC will use 10 grams of egg white solid and be followed by an open feeding of egg
At selected visits blood and urine collection physical examination prick skin tests and atopic dermatitis and asthma evaluations will occur
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 |
|---|---|---|---|
| U19AI066738 | NIH | None | httpsreporternihgovquickSearchU19AI066738 |
| COFAR | None | None | None |