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Trial record 1 of 2 for:    fauquert
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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

Tracking Information
First Submitted Date  ICMJE January 23, 2014
First Posted Date  ICMJE January 27, 2014
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE July 2013
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
Official Title  ICMJE Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peanut Allergy
Intervention  ICMJE Drug: arachid
Study Arms  ICMJE
  • 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
    Intervention: 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
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 23, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2017
Estimated Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02046083
Other Study ID Numbers  ICMJE CHU-0177
2013-A00169-36
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Luc FAUQUERT University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP