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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001505-28-IT

Enrollment

140

Registered

2006-05-25

Start date

2006-05-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anaphylactic reactions due to hymenoptera stings MedDRA version: 6.1 Level: PT Classification code 10002198

Interventions

Pharmaceutical Form: Emulsion for injection INN or Proposed INN: Insects Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 100-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026