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

Primary Purpose

Peanut Allergy

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

arachid

About this trial

This is an interventional treatment trial for Peanut Allergy focused on measuring Teenager, Peanut, OIT (Oral Induction Tolerance)

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

treatment

placebo

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase

Percentage of patients with adverse effects during induction phase

Modifications of the immune profile showing a desensitization to peanut

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

Full Information

NCT ID

NCT02046083

First Posted

January 23, 2014

Last Updated

January 23, 2014

Sponsor

University Hospital, Clermont-Ferrand

1. Study Identification

Unique Protocol Identification Number

NCT02046083

Brief Title

Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Acronym

PITA 3

Official Title

Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Clermont-Ferrand

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peanut Allergy

Keywords

Teenager, Peanut, OIT (Oral Induction Tolerance)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

treatment

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

arachid

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Percentage of patients had quadrupled their tolerance to peanut at the end of induction phase

Time Frame

at 24 weeks

Title

Percentage of patients with adverse effects during induction phase

Time Frame

at 24 weeks

Title

Modifications of the immune profile showing a desensitization to peanut

Time Frame

at 24 weeks

Title

Time Frame

at 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Patrick LACARIN

Phone

04 73 75 11 95

placarin@chu-clermontferrand.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Luc FAUQUERT

Organizational Affiliation

University Hospital, Clermont-Ferrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patrick LACARIN

Phone

0473751195

placarin@chu-clermontferrand.fr

12. IPD Sharing Statement

Citations:

PubMed Identifier

25925398

Citation

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.

Results Reference

derived

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Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

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