Oral Peanut Immunotherapy for Peanut Allergic Patients

NCT01891136 | Completed Early Phase 1 DMC

• 1 other identifier: 11-2298
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to determine if peanut oral immunotherapy (OIT) would desensitize or tolerize peanut allergic patients to peanuts in order prevent peanut allergic reactions.

Conditions

Peanut Hypersensitivity

Keywords

Peanut allergy

Outcome Measures

Primary Outcomes (2)

• The percentage of peanut-allergic patients achieving clinical desensitization to peanut, assessed after up to five years of OIT.

  Clinical desensitization will be measured with an oral food challenge (OFC) to peanut conducted while on OIT therapy.

  2 to 5 years

• Clinical desensitization will be measured with an oral peanut challenge conducted while on OIT therapy.

  Clinical tolerance will be measured with an oral peanut challenge conducted four weeks after discontinuing OIT.

  2 to 5 years

Secondary Outcomes (2)

• Changes in number of antigen-specific lymphocytes.

  2 to 5 years

• Changes in function of antigen-specific lymphocytes.

  2-5 years

Study Arms (1)

Peanut protein

EXPERIMENTAL

Subjects to receive varying amounts of peanut protein as peanut oral immunotherapy.

Drug: Peanut protein

Interventions

Peanut protein DRUG

Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.

Also known as: Peanut OIT

Peanut protein

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects between 1 and 16 years of age
• Diagnosed peanut allergy by either: 1) a positive prick skin test to peanut, CAP FEIA of 15 or greater and a history of significant clinical symptoms within one hour after ingestion of peanuts or 2) a positive prick skin test to peanut, CAP FEIA of ≥ 7 and a history of a clinical reaction to peanut ingestion within the past 6 months.
• A family that will be able to be compliant with all study visits.

You may not qualify if:

• Subjects with a history of severe anaphylaxis to peanut
• Subjects with a medical history that would prevent a DBPCFC/OFC to peanut The medical history that would prevent the DBPCFC to peanut would be a prior history of an open peanut challenge in which the patient experienced hypotension which required fluid resuscitation, respiratory compromise which necessitated ventilatory support, or poorly controlled asthma as evidenced by an forced expiratory volume in 1 second (FEV1) \< 80% of predicted, or FEV1/FVC (forced vital capacity) \< 75%, with or without controller medications
• Subjects unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
• Pregnant or lactating
• Allergy to oat

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Wesley Burks, MD

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: July 2, 2013
• Study Start: April 1, 2004
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: June 25, 2015

Record last verified: 2015-06

Locations

US (1)