Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-07

Study Completion Date

2023-01-20

Brief Summary

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Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients

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Detailed Description

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This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care.

Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Conditions

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Rhinoconjunctivitis With or Without Allergic Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Beltavac® Polymerized with Alternaria alternata

Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis
* Positive skin testing or IgE determination to the relevant allergen

Exclusion Criteria

Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No