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

• Sponsor: Roxall Medicina España S.A (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04112797
• Collaborator: (none)
• Enrollment: 50
• Locations: 8
• Anticipated Duration (Months): 53.3
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Allergy to Himenoptera Venom	Biological: Allergovac himenoptera

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Observational Study to Evaluate the Safety of Treatment With A"LLERGOVAC® HIMENÓPTEROS" in Patients Sensitized to This Venom
• Actual Study Start Date: May 23, 2019
• Anticipated Primary Completion Date: Nov 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Outcome Measures

Primary Outcome Measures

1. Number of participants with treatment-related adverse events as assessed by WAO classification [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.

Secondary Outcome Measures

1. Efficacy of vaccine evaluating re-sting test [Result of the re-sting test]

   Grade of treatment protection after controlled sting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

1. Prescription treatment with Hymenoptera venom must be indicated and patients are susceptible to receive Allergovac® Hymenoptera, according to usual clinical practice.

2. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Hospital Fundación Alcorcón	Madrid		Spain	28922
6	Hospital Universitario Reina Sofia	Murcia		Spain
7	Hospital Joan XXIII	Tarragona		Spain	43005
8	Hospital Universitario La Fe	Valencia		Spain	46026

Sponsors and Collaborators

• Roxall Medicina España S.A

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roxall Medicina España S.A
• ClinicalTrials.gov Identifier: NCT04112797
• Other Study ID Numbers: ROX-ALE-2018-02
• First Posted: Oct 2, 2019
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 17, 2022