Randomised, parallel phase IV study on the safety of hymenoptera venom immunotherapy - ND

Conditions: anaphylactic reactions due to hymenoptera stings
MedDRA version: 6.1Level: PTClassification code 10002198

Registration Number: EUCTR2006-001505-28-IT

Lead Sponsor: AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

Patients aged 12-70 yrs old Written informed consent History an anaphylactic reaction due to hymenoptera sting Cutaneous tests positive to honeybee or yellow jacket venoms and/or CAP-system positive values
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

patients with a sensitisation to wasp venom, clinically significant the exclusion criteria included in the last Position Paper

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to evaluate the tolerability of purified and standard non-purified hymenoptera venom products for the incremental phase ultra-rush of immunotherapy;Secondary Objective: to evaluate the safety of the change of an aqueous product for the incremental phase of immunotherapy to a retard extract Alutard SQ for the maintenance phase;Primary end point(s): to evaluate the tolerability of purified and standard non-purified hymenoptera venom products for the incremental phase ultra-rush of immunotherapy

Secondary Outcome Measures