ong-term follow-up (up to 3 years) to investigate the maintenance of efficacy and safety of AllerT, a drug based on modified peptides of Bet V 1, applied in two different dosages to subjects suffering from birch pollen allergy during the trial AN004T

• Conditions: ong-term follow-up of desensitization by Specific ImmunoTherapy (SIT) received during the trial AN004T in subjects allergic to birch pollen; MedDRA version: 16.1Level: LLTClassification code 10066093Term: Birch pollen allergySystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-003881-15-SE
• Lead Sponsor: Anergis SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified