Oral Peanut Immunotherapy

NCT01324401 | Completed Results

• 1 other identifier: 2010P000609
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Peanut allergy is one of the most serious food allergies because of its life long persistence, and the potential for severe allergic reactions. Effective oral immunotherapy would benefit patients by reducing the likelihood that they will have life-threatening accidental allergic reactions. This research study is being done to develop an effective oral immunotherapy treatment for patients with peanut allergy.

Conditions

Peanut Allergy

Keywords

Peanut Allergy; Peanut Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Tolerance or Sustained Unresponsiveness

  The consumption of 5 grams of peanut protein during a double-blind placebo controlled food challenge without objective symptoms after one month of post treatment avoidance

  at least 36 months

Secondary Outcomes (1)

• Desensitization

  at least 36 months

Study Arms (2)

Control

NO INTERVENTION

The subjects randomized to the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. These subjects are then offered to cross-over to active treatment.

Peanut OIT

EXPERIMENTAL

The subjects randomized to the active treatment group will receive defatted peanut flour per protocol.

Drug: Peanut flour OIT

Interventions

Peanut flour OIT DRUG

Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.

Peanut OIT

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of peanut allergy by a positive prick skin test to peanut (\> 8 mm reaction wheal) or CAP FEIA \>10 and a history of objective clinical symptoms within one hour after ingestion of peanuts
• Ability to provide informed consent.
• Males and females of all ethnic/racial groups between 7 and 21 years who are otherwise healthy.

You may not qualify if:

• Clinical history of a severe anaphylactic reaction known or suspected to be caused by ingestion of peanut that required treatment with 2 or more administrations of epinephrine or hospitalization
• Moderate to Severe Asthma as defined using the Impairment or Risk Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
• Poorly controlled Asthma as defined using the Control Criteria of the current NHBLI Guidelines for the Diagnosis and Management of Asthma (http://www.nhlbi.nih.gov/guidelines/asthma/)
• Diagnosis of other severe or complicating medical problems
• Autoimmune or chronic immune or gastrointestinal inflammatory conditions, including Celiac Disease, Inflammatory Bowel Disease and Eosinophilic Gastrointestinal Disorders
• Primary Immune Deficiency
• Use of beta blockers, angiotension converting enzyme inhibitors, or monoamine oxidase inhibitors
• Women of childbearing potential who are pregnant, planning to become pregnant, or breastfeeding
• Use within the past year of other systemic immunomodulatory treatment, including allergen immunotherapy, use of biologics with an immune target, including Xolair

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Food Allergy Center; Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Wayne Shreffler
• Organization: Harvard Medical School / Massachusetts General Hospital

wshreffler@mgh.harvard.edu

617-726-6147

Study Officials

• Wayne G Shreffler, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Center for Immunology and Inflammatory Diseases; Director, Food Allergy Center

Model Details: The observational control arm (parallel for the first year) was then offered to cross over to active treatment

Study Record Dates

• First Submitted: August 12, 2010
• First Posted: March 29, 2011
• Study Start: March 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2018
• Last Updated: August 8, 2018
• Results First Posted: January 20, 2017

Record last verified: 2018-07

Locations

US (1)