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

NCT ID: NCT03963947

Last Updated: 2023-05-25

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

97 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-05-24

Brief Summary

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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

Detailed Description

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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.

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 house dust mites

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Probelte Pharma S.L.U.

INDUSTRY

Sponsor Role collaborator

Alfons Malet i Casajuana

OTHER

Sponsor Role lead

Responsible Party

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Alfons Malet i Casajuana

Head of Allergy Service in Teknon Medical Center

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Teknon Medical Center

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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MAL-BEL-2018-01

Identifier Type: -

Identifier Source: org_study_id

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