Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Peanut Allergy Clinical Trial

— PITA 3  

Official title:

Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02046083
• Other study ID #: CHU-0177
• Secondary ID: 2013-A00169-36
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 23, 2014
• Last updated: January 23, 2014
• Start date: July 2013
• Est. completion date: January 2017

Study information

• Verified date: January 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Description:

Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Drug:
• arachid

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		at 24 weeks	Yes
Secondary	Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase		at 24 weeks	Yes
Secondary	Percentage of patients with adverse effects during induction phase		at 24 weeks	Yes
Secondary	Modifications of the immune profile showing a desensitization to peanut		at 24 weeks	Yes
Secondary	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	Yes