NCT01259804

Brief Summary

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

4 years

First QC Date

December 13, 2010

Last Update Submit

January 13, 2015

Conditions

Peanut Allergy

Keywords

peanutfood allergyanaphylaxisimmunotherapy

Outcome Measures

Primary Outcomes (1)

  • Pass/fail peanut challenge

    six months

Study Arms (1)

Peanut immunotherapy

EXPERIMENTAL

Peanut flour

Dietary Supplement: Peanut oral immunotherapy

Interventions

Peanut oral immunotherapyDIETARY_SUPPLEMENT

Daily doses of peanut flour

Also known as: Daily doses peanut flour
Peanut immunotherapy

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Peanut allergy defined by oral challenge

You may not qualify if:

  • Major immunodeficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cambridge Biomedical Campus

Cambridge, Cambridgeshire, CB23 7DS, United Kingdom

Location

Related Publications (3)

  • Clark AT, Islam S, King Y, Deighton J, Anagnostou K, Ewan PW. Successful oral tolerance induction in severe peanut allergy. Allergy. 2009 Aug;64(8):1218-20. doi: 10.1111/j.1398-9995.2009.01982.x. Epub 2009 Feb 17.

    PMID: 19226304RESULT

  • Santos AF, James LK, Kwok M, McKendry RT, Anagnostou K, Clark AT, Lack G. Peanut oral immunotherapy induces blocking antibodies but does not change the functional characteristics of peanut-specific IgE. J Allergy Clin Immunol. 2020 Jan;145(1):440-443.e5. doi: 10.1016/j.jaci.2019.09.005. Epub 2019 Oct 30. No abstract available.

    PMID: 31676085DERIVED

  • Anagnostou K, Clark A, King Y, Islam S, Deighton J, Ewan P. Efficacy and safety of high-dose peanut oral immunotherapy with factors predicting outcome. Clin Exp Allergy. 2011 Sep;41(9):1273-81. doi: 10.1111/j.1365-2222.2011.03699.x. Epub 2011 Mar 18.

    PMID: 21414048DERIVED

MeSH Terms

Conditions

Peanut HypersensitivityFood HypersensitivityAnaphylaxis

Condition Hierarchy (Ancestors)

Nut and Peanut HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Andrew T Clark, MB BD MD

    Cambridge Biomedical Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 14, 2010

Study Start

January 1, 2008

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations

GB(1)