Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers (PITA 3)
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ClinicalTrials.gov Identifier: NCT02046083 |
Recruitment Status : Unknown
Verified January 2014 by University Hospital, Clermont-Ferrand.
Recruitment status was: Recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peanut Allergy | Drug: arachid | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers |
Study Start Date : | July 2013 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | January 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: treatment
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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Drug: arachid |
Placebo Comparator: placebo
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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- 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 [ Time Frame: at 24 weeks ]
- Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase [ Time Frame: at 24 weeks ]
- Percentage of patients with adverse effects during induction phase [ Time Frame: at 24 weeks ]
- Modifications of the immune profile showing a desensitization to peanut [ Time Frame: 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 [ Time Frame: at 24 weeks ]

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Ages Eligible for Study: | 12 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adolescents between 12 and 18 years
- Clinical History of allergic manifestation within one hour of ingestion of peanuts or Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) peanut positive below the threshold of 2 grams
- Bad reaction peanut demonstrated by positive Patch Test (PT ≥ 3 mm above the negative control) and specific IgE f13> 12 IU / mL and / or rAra h2> 5.8 IU / mL
- Previous follow at least 1 year
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
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Incapacity
- to establish a daily logbook of clinical monitoring
- to support severe reaction after eating peanut
- to follow a regular peanut ingestion protocol

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046083
Contact: Patrick LACARIN | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
France | |
CHU Clermont-Ferrand | Recruiting |
Clermont-Ferrand, France, 63003 | |
Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr |
Principal Investigator: | Jean-Luc FAUQUERT | University Hospital, Clermont-Ferrand |
Responsible Party: | University Hospital, Clermont-Ferrand |
ClinicalTrials.gov Identifier: | NCT02046083 |
Other Study ID Numbers: |
CHU-0177 2013-A00169-36 |
First Posted: | January 27, 2014 Key Record Dates |
Last Update Posted: | January 27, 2014 |
Last Verified: | January 2014 |
Teenager Peanut OIT (Oral Induction Tolerance) |
Peanut Hypersensitivity Nut and Peanut Hypersensitivity Food Hypersensitivity |
Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |