Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers (PITA 3)

• ClinicalTrials.gov Identifier: NCT02046083
• Recruitment Status: Unknown
• First Posted: January 27, 2014
• Last Update Posted: January 27, 2014
• Sponsor: University Hospital, Clermont-Ferrand
• Information provided by (Responsible Party): University Hospital, Clermont-Ferrand

Tracking Information

• First Submitted Date: January 23, 2014
• First Posted Date: January 27, 2014
• Last Update Posted Date: January 27, 2014
• Study Start Date: July 2013
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
• Official Title: 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: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Peanut Allergy
• Intervention: Drug: arachid

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 23, 2014): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2017
• Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02046083
• Other Study ID Numbers: CHU-0177; 2013-A00169-36
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University Hospital, Clermont-Ferrand
• Study Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jean-Luc FAUQUERT; University Hospital, Clermont-Ferrand

• PRS Account: University Hospital, Clermont-Ferrand
• Verification Date: January 2014