ong-term, up to 3-year follow-up of a multicentre, randomized, double-blind, placebo-controlled trial (AN004T) assessing the efficacy and tolerability of 2 dosing regimens of AllerT, a combinationof contiguous overlapping peptides derived from Bet v 1, in adult subjects allergic to birch pollen

Anergis SA0 个研究点目标入组 238 人开始时间: 2013年11月25日最近更新: 2014年11月10日

试验速览

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•Subjects satisfying all the following criteria could be included in the trial.
•1. Had been randomized in the AN004T trial and had received at least 1 injection
•2. Have been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 238
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any subject presenting with one or more of the following criteria will not be included in the trial. These exclusion criteria are valid for each year.
•1. Received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
•2. Intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
•3. Unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
•4. Not covered by medical insurance
•5. Received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
•6. Received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
•7. Used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period

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