NCT02046083
Unknown
Phase 2
Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers
University Hospital, Clermont-Ferrand1 site in 1 country60 target enrollmentStarted: July 2013Last updated:
Overview
- Phase
- Phase 2
- Sponsor
- University Hospital, Clermont-Ferrand
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 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
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- 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
- •Incapacity
- •to establish a daily logbook of clinical monitoring
- •to support severe reaction after eating peanut
Arms & Interventions
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
Intervention: arachid (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- 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)
- Modifications of the immune profile showing a desensitization to peanut(at 24 weeks)
Investigators
Study Sites (1)
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