Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
NCT ID: NCT07309822
Last Updated: 2025-12-30
Study Results
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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RECRUITING
27 participants
OBSERVATIONAL
2025-02-01
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Written informed consent, duly signed and dated by the patient or by the legal representative in the case of minors.
* Assent form duly signed and dated by the minor, when applicable.
* Patients with allergy to Apis mellifera, Vespula spp., or Polistes dominula who have experienced a systemic reaction following a hymenoptera sting, either with involvement of multiple organs or exclusively cutaneous.
* Positive intradermal test (mean wheal diameter ≥ 5 mm) with Beltaven® diagnostic (allergenic extract of Apis mellifera, Vespula spp., or Polistes dominula).
* Positive specific IgE test from class 1 onwards (≥ 0.35 kUA/L).
* Patients willing to receive immunotherapy with Beltaven®.
Exclusion Criteria
* Patients with known allergy to any of the vaccine excipients.
* Pregnant patients, patients planning to become pregnant during the study period, or breastfeeding patients.
* Patients who have received hymenoptera immunotherapy within the 5 years prior to inclusion or during the study.
* Patients who are to receive immunotherapy with another specific allergen different from the investigational treatment during the study period.
* Patients with confirmed sensitization to two or more hymenoptera species as demonstrated by CAP inhibition testing.
* Patients with thrombocytopenic purpura and vasculitis, rhabdomyolysis, or renal failure.
14 Years
ALL
No
Sponsors
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Probelte Pharma S.L.U.
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario Vall d' Hebron
Barcelona, Barcelona, Spain
Hospital Universitario de Bellvitge
Barcelona, , Spain
Xarxa Assistencial I Universitària de Manresa
Barcelona, , Spain
Hospital General Universitario de Castellón
Castellon, , Spain
Hospital General la Mancha Centro
Ciudad Real, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Universitario Reina Sofía
Córdoba, , Spain
Hospital Santa Caterina de Girona
Girona, , Spain
Hospital Universitario Santa María de Lleida
Lleida, , Spain
Hospital Universitario Fundación Alcorcón
Madrid, , Spain
Hospital Universitario la Paz
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Vega Baja
Orihuela, , Spain
Countries
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Central Contacts
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Facility Contacts
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Moisés Labrador
Role: primary
Gustavo Jorge Molina
Role: primary
Laia Ferré
Role: primary
Paula Viedma
Role: primary
Estefanía Moreno
Role: primary
Alberto Palacios
Role: primary
Berta Ruiz
Role: primary
Laia Prat
Role: primary
Lluís Marquès
Role: primary
Teresa Alfaya
Role: primary
Magdalena Lluch
Role: primary
David González de Olano
Role: primary
Ángel Ferrer
Role: primary
Other Identifiers
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PRO-VEN-2023-01
Identifier Type: -
Identifier Source: org_study_id