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

May 24, 2023 updated by: Alfons Malet i Casajuana

Observational Prospective 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

97

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Teknon Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients from 3 to 11 years, who suffer from allergic rhinitis or rhinoconjunctivitis associated with or not with asthma caused by house dust mites

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numbers of treatment-related local and systemic reactions
Time Frame: 1 Year
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 Year
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)
1 Year
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"
1 Year
IgE and IgG4 specific quantification
Time Frame: 1 Year
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alfons Malet i Casajuana

Collaborators

Probelte Pharma S.L.U.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

May 24, 2023

Study Completion (Actual)

May 24, 2023

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

May 23, 2019

First Posted (Actual)

May 28, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • MAL-BEL-2018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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