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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02143583 |
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Date of registration:
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02/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment
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Scientific title:
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Long-term Follow-up of a Multicentre, Randomized, Double-blind, Placebo-controlled Trial (AN004T) Assessing the Efficacy and Tolerability of 2 Dosing Regimens of AllerT in Adult Subjects Allergic to Birch Pollen |
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Date of first enrolment:
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February 2014 |
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Target sample size:
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196 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02143583 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Denmark
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France
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Latvia
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Lithuania
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Poland
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Sweden
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Switzerland
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Contacts
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Name:
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Framçois SPERTINI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Lausanne Hospitals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Any subject having been randomized in the AN004T trial and had received at least one
injection
2. Any subject having been informed and provided signed consent for participating in the
trial and willing to follow all planned trial assessments
Exclusion Criteria:
1. Any subject having received specific immunotherapy against birch pollen or a tree
pollen mix including birch pollen at any time since AN004T and before Visit 1
2. Any subject intending to travel during the birch pollen season outside of the birch
pollination area for more than 7 consecutive days
3. Any subject unable or unwilling to record allergy symptoms and medications daily
during the following birch pollen season using an electronic diary device
4. Any subject not covered by medical insurance
5. Any subject having received immunosuppressive medication within 4 weeks prior to
inclusion, or planned to be used during the trial period
6. Any subject having received systemic or local antihistamines, oral or inhaled
corticosteroids or under anti depressant medication with antihistamine effect within 2
weeks prior to inclusion
7. Any subject having 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
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Birch Pollen Allergy
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Primary Outcome(s)
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Average of the Combined Rhinoconjunctivitis Symptom and Medication Score (RSMS) Obtained Daily During the Birch Pollen Season
[Time Frame: from the first of 3 consecutive days with a regional pollen count > 10 grains/m3 to the earliest between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count = 10 grains/m3]
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Secondary Outcome(s)
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Average of the Total Score of the Validated Mini Rhinoconjunctivitis Quality-of-life Questionnaire© (Mini RQLQ) Obtained Weekly During the Birch Pollen Season
[Time Frame: between the 42nd day after the start of the season and the last day in the last occurrence of 3 consecutive days with a regional pollen count = 10 grains/m3]
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Secondary ID(s)
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AN005T
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2013-003881-15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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