Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Cat Dander

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

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2023-02-09

Brief Summary

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Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Cat Dander 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 with cat dander allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 5 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 cat dander

Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients of the age of 12 years and older suffering from a clinically relevant cat dander induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
* Positive skin testing
* Positive Serum-Specific IgE determination
* Informed consent

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
* Patients with previous immunotherapy with this allergen or another allergen with cross-reaction
* Patients with immunotherapy treatment at the time of inclusion

Minimum Eligible Age

12 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No