Actively Recruiting
Observational Study of Beltaven Injection Therapy for Allergy to Apis Mellifera, Polistes Dominula, or Vespula Species in Patients Aged 14 and Older
Led by Probelte Pharma S.L.U. · Updated on 2025-12-30
27
Participants Needed
13
Research Sites
30 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Beltaven, a subcutaneous allergen-specific immunotherapy, in patients allergic to Apis mellifera, Polistes dominula, or Vespula species. This prospective, open, multi-center observational study includes children and adults receiving care in routine medical practice. The study focuses on patients who have had systemic allergic reactions to hymenoptera stings, aiming to better understand how Beltaven works in real-world settings. Participants receive Beltaven as part of their usual medical care, following a 3-week cluster dosing schedule. The study monitors clinical effectiveness over a 9-month period to assess how the treatment impacts allergic responses. This non-interventional design means that treatments are given as prescribed by doctors, without altering standard care practices. The study collects data during this period to provide insights into Beltavens use in everyday healthcare. During the study, participants will undergo allergy testing including intradermal tests and specific IgE blood tests to confirm their allergy. Researchers will monitor safety and treatment outcomes throughout the 9 months of therapy. The primary measurement is the clinical effectiveness of Beltaven given subcutaneously. Participants health status and any reactions will be observed, with ongoing assessments to ensure safety and support comprehensive data collection over the study timeline.
CONDITIONS
Brief Title
Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
Research Team
I
Inmaculada Buendía Jiménez, DVM
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