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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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12 December 2020 |
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Main ID: |
NCT03127436 |
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Date of registration:
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13/04/2017 |
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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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Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe
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Scientific title:
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A Prospective, Open, Non-interventional Study to Assess the Tolerability and the Safety Profile of SCIT Therapy With Acarovac® Hausstaubmilbe in Patients With HDM-induced Rhinoconjunctivitis With or Without Allergic Asthma |
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Date of first enrolment:
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March 1, 2017 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03127436 |
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Study type:
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Observational [Patient Registry] |
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Study design:
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Phase:
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Countries of recruitment
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Austria
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Contacts
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Name:
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Matthias Kramer, Prof. Dr. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bencard Allergie GmbH |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients of the age of 5 years and older suffering from a house dust mite induced
allergic rhinitis
Exclusion Criteria:
- Patients suffering from acute or chronic infections or inflammations
- Patients suffering from secondary modifications of the target organ with function
impairment (emphysema, bronchiectasis)
- Patients suffering from severe and uncontrolled asthma
- Patients with a known severe autoimmune disease
- Patients with active malignant disease
- Patients requiring beta-blockers
- Patients having any contraindication for the use of adrenaline
- Patients with a hypersensitivity to the excipients of the drug
Age minimum:
5 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Perennial Allergic Rhinitis
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Intervention(s)
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Drug: Acarovac
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Primary Outcome(s)
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Numbers of treatment-related local and systemic reactions following SCIT administration
[Time Frame: over the overall duration of the study]
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Secondary Outcome(s)
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Safety and Tolerability - frequency and intensity of adverse events
[Time Frame: over the overall duration of the study]
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Safety and Tolerability - local reactions at injection site
[Time Frame: over the overall duration of the study]
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Safety and Tolerability - Number of systemic reactions
[Time Frame: over the overall duration of the study]
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Changes in rhinoconjunctivitis score
[Time Frame: baseline and 3-6 month, depending on the intervals between the injections and the applied up-dosing scheme]
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Secondary ID(s)
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Acarovac AT
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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