Peanut Allergy Clinical Trial
— FASTXOfficial title:
Explorative Open Phase II-study, Food Allergy Suppression Therapy During Protection With Xolair
Verified date | August 2018 |
Source | Karolinska Institutet |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).
Status | Active, not recruiting |
Enrollment | 23 |
Est. completion date | October 2020 |
Est. primary completion date | October 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 22 Years |
Eligibility |
Inclusion Criteria: - IgE to peanut, Ara h 1, Ara h 2 and Ara h 3 - IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc. - Clinical allergic reactions to peanut the last 5 years - Positive conjunctival challenge to the selected airborne allergen - Positive CD-sens to peanut and the selected airborne allergen - IgE according to the recommendations of the manufacturer - Written consent Exclusion Criteria: - No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases - Pregnancy - No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab |
Country | Name | City | State |
---|---|---|---|
Sweden | Sachs´ Children´s Hospital, Södersjukhuset | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Caroline Nilsson |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peanut challenge. The peanut challenge can be positive i.e. the study object reacts to peanuts with allergic symptoms or negative i.e. no reaction in two hours after completed challenge. | The participants will be followed for the duration of Xolair treatment and oral immunotherapy, an expected average of 1 year |
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