Patients with previous systemic reaction to honeybee sting (Müller stage I-III) MedDRA version: 7.0 Level: LLT Classification code 10001751
Conditions
Interventions
Product Name: Purethal Bee
Pharmaceutical Form: Injection*
Other descriptive name: Bee Venom
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pha
Sponsors
HAL Allergy B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patient with a history of systemic reaction (grade 1 to grade 4, according to Müller classification) after a bee sting. However, patients who had pulmonary or cardiac arrest, and have survived the sting reaction only with the help of resuscitation measures, should not be included into the study. · Positive IC test with bee venom HEIC > 0.5 at 0.1 µg/ml · RAST positive (= 2) for specific bee IgE · Age: 18 years or older Are the trial subjects under 18? no 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: · History of immunotherapy treatment with bee venom · Chronic asthma or emphysema, particularly with a FEV1 < 70% of predicted value or use of corticosteroids · Serious immunopathologic diseases or malignancies (including auto-immune diseases, tuberculosis) · Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension · Diseases with a contra-indication for the use of adrenaline · Severe kidney disease · Use of systemic steroids · Treatment with b-blockers or immunosuppressive drugs · Severe atopic dermatitis · Mastocytosis · Participation in a clinical study with a new investigational drug during the last 3 months · Pregnancy, lactation or inadequate contraceptive measures · Alcohol- or drug abuse · Lack of co-operation or severe psychological disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show that Purethal Bee is a safe and effective treatment to reduce allergic reactions to a honeybee sting in patients that had previous shown a systemic reaction to such a sting;Secondary Objective: ;Primary end point(s): Systemic reactions to re-sting | — |
Countries
Germany
Outcome results
None listed