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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Peanut Allergy Drug: arachid Phase 2 Phase 3

Detailed Description:
Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance
Study Design
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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
Arms and Interventions
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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
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase [ Time Frame: at 24 weeks ]
  2. Percentage of patients with adverse effects during induction phase [ Time Frame: at 24 weeks ]
  3. Modifications of the immune profile showing a desensitization to peanut [ Time Frame: at 24 weeks ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  • Incapacity

    • to establish a daily logbook of clinical monitoring
    • to support severe reaction after eating peanut
    • to follow a regular peanut ingestion protocol
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Jean-Luc FAUQUERT University Hospital, Clermont-Ferrand
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by University Hospital, Clermont-Ferrand:
Teenager
Peanut
OIT (Oral Induction Tolerance)
Additional relevant MeSH terms:
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Peanut Hypersensitivity
Nut and Peanut Hypersensitivity
Food Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases