NCT07309822 Study to Assess the Safety and Effectiveness of Beltaven® in Patients With Allergy to Apis Mellifera, Polistes Dominula or Vespula Spp.
| NCT ID | NCT07309822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Probelte Pharma S.L.U. |
| Condition | Allergy |
| Study Type | OBSERVATIONAL |
| Enrollment | 27 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 27 participants in total. It began in 2025-02-01 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility Criteria
Inclusion Criteria: * Age 14 years or older at the time of study inclusion. * 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 severe cardiovascular diseases, active malignant neoplasms or malignancies in remission within the last 5 years, non-stabilized systemic or organ-specific autoimmune diseases, severe mental disorders, or other relevant chronic diseases that may interfere with the study results. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07309822 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07309822 currently recruiting?
Yes, NCT07309822 is actively recruiting participants. Contact the research team at inmaculadabuendia@probeltepharma.es for enrollment information.
Where is the NCT07309822 trial being conducted?
This trial is being conducted at Barcelona, Spain, Barcelona, Spain, Barcelona, Spain, Castellon, Spain and 9 additional locations.
Who is sponsoring the NCT07309822 clinical trial?
NCT07309822 is sponsored by Probelte Pharma S.L.U.. The trial plans to enroll 27 participants.