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NCT Number: NCT03604718

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

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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Key information

Conditions

Rhinoconjunctivitis With or Without Allergic Asthma

Age range

5 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitary Hospital of Vic, Vic, Barcelona, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beltavac® Polymerized with Alternaria alternata

Biological

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

Primary outcomes

  1. Numbers of treatment-related local and systemic reactions

    Time frame: 1 year

    Number of adverse reactions occurred during the treatment period and classified according to the WAO standard

Secondary outcomes

  1. Rhinoconjuntivitis medication intake

    Time frame: 1 year

    Medication intake for allergy symptons control at baseline, 6 and 12 months

  2. Visual analogue Scale Score

    Time frame: 1 year

    Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:"no symptoms" to 10 "highest level of symptoms"

  3. IgE and IgG4 specific quantification

    Time frame: 1 year

    IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months

Sponsors and collaborators

Lead sponsor

Probelte Pharma S.L.U.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2018
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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