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Completed

NCT Number: NCT03963947

Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerised With House Dust Mite in pediatric allergic patients

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Key information

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Teknon Medical Center

Barcelona, Spain

About this study

This prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac polymerized with house dust mite pediatric allergic patients 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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients from 3 to 11 years suffering from a clinically relevant Dermatophagoides farinae and Dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma
  • Positive skin testing
  • Positive Serum-Specific IgE determination
  • Parental or legal representative informed consent
  • Clinical sintomatology on the inclusion period

Exclusion criteria

  • Patients suffering from acute or chronic infections or inflammations
  • Patients suffering from uncontrolled and severe 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

Treatment and study plan

Beltavac® Polymerized with house dust mites

Biological

Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice

Primary outcomes

  1. Numbers of treatment-related local and systemic reactions

    Time frame: 1 Year

Secondary outcomes

  1. Combined symtom and medication score of Rhinoconjunctivitis

    Time frame: 1 Year

    The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

  2. Combined symtom and medication score of Asthma

    Time frame: 1 Year

    The score will be calculated as a sum of the symptoms score (0-3) and medication score (0-3)

  3. 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"

  4. IgE and IgG4 specific quantification

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Alfons Malet i Casajuana

Other

Collaborators

  • Probelte Pharma S.L.U.

Registry information

Official study title

Observational Prospective Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With House Dust Mites

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 28, 2019
Registry last updated
May 25, 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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