- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03849079
Validation of the HYPONUT Product
November 23, 2020 updated by: University Hospital, Montpellier
Clinical Validation of the Inactivation Procedure for Peanut Major Allergens in the HYPONUT Product
The HYPONUT product was previously validated in a laboratory setting ("Procédé de préparation d'aliment hypoallergénique", n° FR1250977) on 2012.
A international patent was then obtained on 2013.
Through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting.
Patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges.
In vitro tests are also performed (i.e.
IgE levels for peanut and peanut components).
The follow-up of patients consists in regular yearly or semestral evaluations.
During one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well.
When skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hérault
-
Montpellier, Hérault, France, 34090
- University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Patients aged more than 6
- Patients suffering from peanut allergy and followed in the Allergy Unit of the University Hospital of Montpellier (France)
Exclusion criteria:
- Pregnancy, or patients breast-feeding
- Patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines)
- Patients presenting with dermographism
- Patients not fluent in French
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hyponut
|
Prick tests with hyponut
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Skin Prick Tests evaluation
Time Frame: day patient enrolled
|
day patient enrolled
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Oral food challenge evaluation
Time Frame: day patient enrolled
|
day patient enrolled
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2019
Primary Completion (Actual)
February 4, 2020
Study Completion (Actual)
February 4, 2020
Study Registration Dates
First Submitted
February 19, 2019
First Submitted That Met QC Criteria
February 19, 2019
First Posted (Actual)
February 21, 2019
Study Record Updates
Last Update Posted (Actual)
November 27, 2020
Last Update Submitted That Met QC Criteria
November 23, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UF 7542
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peanut Allergy
-
Rima RachidUniversity of MinnesotaRecruitingPeanut Hypersensitivity | Peanut Allergy | Food Allergy | Food Allergy Peanut | Peanut-Induced Anaphylaxis | Allergy, PeanutUnited States
-
Novartis PharmaceuticalsTerminatedAllergy, PeanutUnited States, Germany, Japan, Australia, France, Spain, Denmark, Canada, Italy, Netherlands
-
University of ManitobaThe Hospital for Sick Children; University of British Columbia; McGill UniversityEnrolling by invitationAllergy to Peanut
-
Scripps HealthThe Scripps Research InstituteWithdrawnFood Allergy PeanutUnited States
-
Imperial College LondonUniversity of Sydney; National Institute for Health Research, United KingdomCompletedIgE Mediated Peanut AllergyUnited Kingdom
-
King's College LondonCharite University, Berlin, Germany; University Hospital, Bonn; Institut Curie; Levantine UKNot yet recruitingAllergy;Food | Food Allergy Peanut | Pathways and Sources of Exposure
-
Imperial College LondonUniversity College CorkActive, not recruitingPeanut Hypersensitivity | IgE Mediated Peanut AllergyUnited Kingdom
-
National Institute of Allergy and Infectious Diseases...Genentech, Inc.; Novartis Pharmaceuticals; Rho Federal Systems Division, Inc.Active, not recruitingPeanut Allergy | Multi-food AllergyUnited States
-
University of RochesterNational Institute of Allergy and Infectious Diseases (NIAID)Not yet recruitingEgg Allergy | Food Allergy Peanut | Food Allergy in Infants | Allergy and Immunology | Peanut and Nut AllergyUnited States
-
Scott SichererNational Institute of Allergy and Infectious Diseases (NIAID)CompletedPeanut Allergy | Food AllergyUnited States