A multicentre, open-label clinical trial to assess plasma levels and safety of bilastine in children from 2 to 5 years of age with seasonal and/or perennial allergic rhinoconjunctivitis or urticaria

FAES FARMA S.A.0 个研究点目标入组 39 人开始时间: 2021年9月13日最近更新: 2022年5月30日

适应症

试验速览

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•1. Boys and girls between the ages of 2 and 5 years, inclusive, at V1 screening.
•2. Weight = 10 kg.
•3. Documented history of mild to moderate seasonal and/or perennial allergic rhinoconjunctivitis or urticaria before or during V1. Subjects must be symptomatic at screening as judged by the investigator, and therefore, susceptible to oral antihistamine treatment.
•4. For subjects with allergic rhinoconjunctivitis: Documented positive skin prick test and/or any positive validated IgE test to at least one seasonal (e.g. grass, ragweed, and/or tree pollen etc.) and/or perennial allergen (e.g. cat dander, dog dander, dust mites and/or cockroach etc.) within lifetime before V1 or a positive skin prick test / test for specific IgE at V1. A positive skin prick test is defined as one with diameter of the wheal 3 mm greater than the diluent control. A positive IgE test is defined to have a Class 3 positivity of = 3.5 – 17.5 kUA/L.
•5. Subjects who have written consent from their legally accepted representatives (LARs) to participate in the clinical trial.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 39
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Non-allergic rhinoconjunctivitis diagnosis.
•2. Known allergy/hypersensitivity to bilastine or its inactive ingredients.
•3. Intake of prohibited prior and concomitant medication.
•4. Any clinical conditions or relevant history of acute or chronic conditions that in the opinion of the investigator would make the subject unsuitable for the clinical trial or interfere with the objectives of the clinical trial.
•5. Subjects or LARs who are unable to comply with the clinical trial requirements (e.g. attendance to visits, prohibited medication intake etc.) or subjects who are unable to take the trial treatment.
•6. Participation in another clinical trial within 30 days prior to screening or 5 half-lives of IMP (whichever is longer).
•7. Subjects, whose LARs are employees of the investigator or clinical trial site, with direct involvement in the proposed clinical trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator.
•8. Subjects, whose LARs are committed to an institution by virtue of an order issued either by the judicial or other authorities.

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