Actively Recruiting
Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
Led by Probelte Pharma S.L.U. · Updated on 2025-12-30
27
Participants Needed
13
Research Sites
356 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltaven® With Apis mellifera, Polistes dominula or Vespula spp. allergic patients
CONDITIONS
Official Title
Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 14 years or older at the time of study inclusion
- Signed informed consent by the patient or legal representative if minor
- Signed assent form by minors when applicable
- Allergy to Apis mellifera, Vespula spp., or Polistes dominula with systemic reaction after sting, involving multiple organs or only skin
- Positive intradermal test with Beltaven� diagnostic showing mean wheal diameter 5 mm
- Positive specific IgE test from class 1 onwards ( 0.35 kUA/L)
- Willingness to receive immunotherapy with Beltaven�
You will not qualify if you...
- Severe cardiovascular diseases, active malignancies, or malignancies in remission within last 5 years
- Non-stabilized systemic or organ-specific autoimmune diseases
- Severe mental disorders or other significant chronic diseases affecting study results
- Known allergy to any vaccine excipients
- Pregnancy, breastfeeding, or planning pregnancy during study
- Received hymenoptera immunotherapy within 5 years before or during study
- Receiving immunotherapy with a different allergen during study
- Sensitization to two or more hymenoptera species confirmed by CAP inhibition testing
- Conditions like thrombocytopenic purpura, vasculitis, rhabdomyolysis, or renal failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Hospital Universitario Vall d' Hebron
Barcelona, Barcelona, Spain
Actively Recruiting
2
Hospital Universitario de Bellvitge
Barcelona, Spain
Actively Recruiting
3
Xarxa Assistencial I Universitària de Manresa
Barcelona, Spain
Actively Recruiting
4
Hospital General Universitario de Castellón
Castellon, Spain
Actively Recruiting
5
Hospital General la Mancha Centro
Ciudad Real, Spain
Actively Recruiting
6
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain
Actively Recruiting
7
Hospital Universitario Reina Sofía
Córdoba, Spain
Actively Recruiting
8
Hospital Santa Caterina de Girona
Girona, Spain
Actively Recruiting
9
Hospital Universitario Santa María de Lleida
Lleida, Spain
Actively Recruiting
10
Hospital Universitario Fundación Alcorcón
Madrid, Spain
Actively Recruiting
11
Hospital Universitario la Paz
Madrid, Spain
Actively Recruiting
12
Hospital Universitario Ramón y Cajal
Madrid, Spain
Actively Recruiting
13
Hospital Vega Baja
Orihuela, Spain
Actively Recruiting
Research Team
I
Inmaculada Buendía Jiménez, DVM
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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