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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A00169-36 |
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The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy
Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance |
|
| placebo | Placebo Comparator | Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| arachid | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut at the end of the first phase of 24 weeks between treatment and placebo groups | at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase | at 24 weeks | |
| Percentage of patients with adverse effects during induction phase | at 24 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
Lack of response during the initial DBPCFCs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut
Uncontrolled asthma and / or severe over the previous year
Atopic dermatitis uncontrolled
Initial severe anaphylaxis requiring hospitalization in intensive care
Presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other)
Home away from a center could support a severe reaction in emergency
Lack of motivation and understanding of parents and / or child
Incapacity
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc FAUQUERT | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25925398 | Derived | Michaud E, Evrard B, Pereira B, Rochette E, Bernard L, Rouzaire PO, Gourdon-Dubois N, Merlin E, Fauquert JL. Peanut oral immunotherapy in adolescents: study protocol for a randomized controlled trial. Trials. 2015 Apr 29;16:197. doi: 10.1186/s13063-015-0717-y. |
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| ID | Term |
|---|---|
| D021183 | Peanut Hypersensitivity |
| ID | Term |
|---|---|
| D000074924 | Nut and Peanut Hypersensitivity |
| D005512 | Food Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
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| Modifications of the immune profile showing a desensitization to peanut |
| at 24 weeks |
| Percentage of patients which tolerate the cumulative dose of 2 grams of peanut during a Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) after 24 weeks without traces eviction diet after the end of maintenance phase | at 24 weeks |
| D007154 | Immune System Diseases |