Status:
UNKNOWN
Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
Lead Sponsor:
Roxall Medicina España S.A
Conditions:
Allergy to Himenoptera Venom
Eligibility:
All Genders
14+ years
Brief Summary
It is a safety and tolerability study of Allergovac Himenopteros in patients sensitized to Apis mellifera, Polistes Dominula or Vespula spp. To get this aim all adverse reactions will be recorded thro...
Eligibility Criteria
Inclusion
- 1\. Patients over 14 years of age with allergy to bee venom, Polistes or Vespula. To meet this criteria, patients must present a systemic reaction with the bite of one of these insects, plus specific IgE detection in the skin test and / or IgE against the himenoptera venom.
- 2\. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.
- 3\. Patients who have given their written consent. In the case of minors, the assent will always be signed by the parent / legal guardian, in addition to the minor.
Exclusion
- Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
- Patients under treatment with immunotherapy against aeroallergens.
- Patients who have received previous treatment with immunotherapy, with any of the venoms that they are going to receive, in the 5 years prior to the inclusion in the study.
- Patients who under investigator opinion may present difficulties that prevent the comprehension of what was written in the information sheet for the patient, the informed consent or the completion of self-administered questionnaires.
- Patients who are participating in another clinical trial or observational study.
Key Trial Info
Start Date :
May 23 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04112797
Start Date
May 23 2019
End Date
November 1 2023
Last Update
March 17 2022
Active Locations (8)
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1
Hospital Vega Baja Orihuela
Orihuela, Alicante, Spain, 03314
2
Hospital Mexoeiro
Vigo, Pontevedra, Spain, 36313
3
C.H.U. A Coruña
A Coruña, Spain, 15006
4
Hospital Santa Maria
Lleida, Spain, 25198