A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
NCT ID: NCT01675791
Last Updated: 2014-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
637 participants
INTERVENTIONAL
2012-08-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALK tree AIT Placebo
1 AIT administered sublingually every day
ALK tree AIT Placebo
ALK tree AIT 0.5 DU
1 AIT administered sublingually every day
ALK tree AIT 0.5 DU
ALK tree AIT 1 DU
1 AIT administered sublingually every day
ALK tree AIT 1 DU
ALK tree AIT 2 DU
1 AIT administered sublingually every day
ALK tree AIT 2 DU
ALK tree AIT 4 DU
1 AIT administered sublingually every day
ALK tree AIT 4 DU
ALK tree AIT 7 DU
1 AIT administered sublingually every day
ALK tree AIT 7 DU
ALK tree AIT 12 DU
1 AIT administered sublingually every day
ALK tree AIT 12 DU
Interventions
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ALK tree AIT 0.5 DU
ALK tree AIT 1 DU
ALK tree AIT 2 DU
ALK tree AIT 4 DU
ALK tree AIT 7 DU
ALK tree AIT 12 DU
ALK tree AIT Placebo
Eligibility Criteria
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Inclusion Criteria
* Use of symptomatic medication for treatment of birch pollen allergy
* Positive skin prick test to birch extract
* Positive specific IgE against Bet v 1
Exclusion Criteria
* History of uncontrolled asthma within the last 3 months
* FEV1 \< 70% of predicted value in adults or FEV1 \< 80% of predicted value in adolescents
* Previous or ongoing treatment with immunotherapy
12 Years
65 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Locations
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Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, HUS, Finland
Slotervaart Ziekenhuis
Amsterdam, , Netherlands
Countries
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Other Identifiers
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TT-02
Identifier Type: -
Identifier Source: org_study_id
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