Status:
COMPLETED
Epicutaneous Immunotherapy in Peanut Allergy in Children
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
DBV Technologies
Conditions:
Peanut Allergy
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This study aims at showing that Epicutaneous Immunotherapy with peanut proteins is safe and efficacious for desensitizing children with peanut allergy.
Detailed Description
Peanut allergy is a common allergy in the United Sates, with prevalence in the general population as high as 1%. Peanut allergy starts in childhood, its prevalence in children has doubled in the past ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or Female between 5 and 17 years of age at enrollment
- An efficient contraceptive method for girls with childbearing potential. Acceptable methods include sexual abstinence, oral, injectable contraceptive methods, intra uterine device.
- Negative pregnancy test for girls with childbearing potential.
- Child with a documented allergy to peanut, i.e. with peanut-specific IgE (\>5KU/L, ImmunoCAP method) and/or a positive skin prick test to peanut (wheal diameter ≥ 8mm).
- Child able to consume a cumulated quantity of peanut proteins \<250 mg during the baseline DBPCFC.
- Child and his/her legal representative(s) who provide a signed consent form and assent form.
- Child and his/her legal representative(s) whose family and social conditions allow them to understand the protocol and agree to comply in the long term with all study requirements.
- Exclusion criteria :
- Child considered too severely allergic to peanut: with a history of severe anaphylaxis to peanut (with hypotension, loss of consciousness, severe bradycardia, respiratory or cardiac arrest requiring an admission to emergency rooms).
- Child with peanut-specific IgE\<5 KU/L and whose skin prick test to peanut gave a wheal diameter \<8mm).
- Child participating or having participated in a therapeutic study in the last 3 months
- Pregnancy or Breastfeeding
- Child with a generalized eczema
- Child with an immune deficiency
- Diabetic child
- Child allergic to chocolate
- Child or legal representative(s) who did not sign their consent or assent
- Child with no baseline DBPCFC
- Child having reacted to placebo during the baseline DBPCFC
- Child able to consume \> 250 mg of cumulated peanut proteins during the baseline DBPCFC
- Child with a respiratory deficiency or with an uncontrolled asthma.
- Child who could not discontinue oral or I.V. antihistamines or oral or I.V. corticosteroids at least the week prior to Visit 1.
- Child with important skin lesions precluding the application of the disks.
- Child not affiliated to social security.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01197053
Start Date
August 1 2010
End Date
April 1 2015
Last Update
October 20 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Necker
Paris, France, 75015