Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom (HIPNOS)

March 16, 2022 updated by: Roxall Medicina España S.A

Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom

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 through the study. In addition, it will be evaluated the treatment efficacy with the re-sting after a year of treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • A Coruña, Spain, 15006
      • Lleida, Spain, 25198
      • Madrid, Spain, 28922
      • Murcia, Spain
        • Not yet recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
      • Tarragona, Spain, 43005
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:
    • Alicante
      • Orihuela, Alicante, Spain, 03314
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36313
        • Completed
        • Hospital Mexoeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People with allergy to himenoptera venom.

Description

Inclusion Criteria:

  • 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 Criteria:

  1. Patients who have received treatment with Allergovac® Hymenoptera prior to inclusion in the study.
  2. Patients under treatment with immunotherapy against aeroallergens.
  3. 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.
  4. 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.
  5. Patients who are participating in another clinical trial or observational study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by WAO classification
Time Frame: During 1 year
All adverse events ocurred during the study Will be collected and clasified following the WAO recommendations. The percentages Will be exposed by number of patients and by dose administrations.
During 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of vaccine evaluating re-sting test
Time Frame: Result of the re-sting test
Grade of treatment protection after controlled sting
Result of the re-sting test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roxall Medicina España S.A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 23, 2019

Primary Completion (ANTICIPATED)

November 1, 2023

Study Completion (ANTICIPATED)

November 1, 2023

Study Registration Dates

First Submitted

June 18, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (ACTUAL)

October 2, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • ROX-ALE-2018-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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