Safety and Clinical Tolerability of hdmASIT+TM Peptides Administered in HDM-induced Allergic Patients
NCT ID: NCT03094845
Last Updated: 2017-03-29
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
36 participants
INTERVENTIONAL
2016-09-28
2017-01-23
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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Placebo
Placebo solution
15 injections over 7 weeks
hdmASIT+TM
hdmASIT+TM
15 injections over 7 weeks
Interventions
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Placebo solution
15 injections over 7 weeks
hdmASIT+TM
15 injections over 7 weeks
Eligibility Criteria
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Inclusion Criteria
* A positive skin prick test to house dust mite Dermatophagoides pteronyssinus
* Specific IgE against house dust mite Dermatophagoides pteronyssinus ≥ 0.7 kU/L
* Positive response to Conjunctival Provocation Test (CPT)
* Being treated with anti-allergic medication for at least 12 months prior to enrollment
* For asthmatic patients: confirmed diagnosis of controlled asthma according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2014), FEV1 ≥ 80% of the patient's reference value
Exclusion Criteria
* Ongoing immunotherapy with house dust mite allergens or any other allergens
* History of severe systemic reactions and/or anaphylaxis, including to food (e.g. peanut, marine animals) or to Hymenoptera venom (e.g. bee, wasp stings) or to medication (e.g. penicillin), etc.
* Partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2014)
* Chronic asthma or emphysema, particularly with a forced expiratory volume in 1 second (FEV1) \< 80% of the patient's reference value (ECSC)
* History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening
18 Years
64 Years
ALL
No
Sponsors
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ASIT Biotech S.A.
INDUSTRY
Responsible Party
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Locations
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Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Countries
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Other Identifiers
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2016-000557-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABT-hdmASIT001
Identifier Type: -
Identifier Source: org_study_id
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