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Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions. (Venox-23)

I

Inmunotek

Status

Enrolling

Conditions

Insect Sting Allergy
Allergy, Insect Venom
Allergy Insect Stinging

Treatments

Biological: VENOX

Study type

Observational

Funder types

Industry

Identifiers

NCT06790368
ITK-VENOX-2023-01

Details and patient eligibility

About

Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.

Full description

Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.

Enrollment

80 estimated patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
  • Participants of both sexes aged 14 years or more.
  • Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
  • Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.

Exclusion criteria

  • Pregnant or breastfeeding women.
  • Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
  • Participants who do not agree to participate and/or do not sign the informed consent form.
  • Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.

Trial design

80 participants in 1 patient group

Patients allergic to hymenoptera venom
Description:
Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)
Treatment:
Biological: VENOX

Trial contacts and locations

3

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Central trial contact

Miguel Casanovas; Raquel Caballero

Data sourced from clinicaltrials.gov

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