Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

This is an interventional treatment trial for Acute ACE-induced Angioedema Read More

Inclusion Criteria:

• Written informed consent to participate in the study and ability to fulfil all study requirements
• Male or female patients aged >=18 years
• Patients with ACE induced angioedema (grade II-III) with imminent airway obstruction admitted to an Emergency department
• Patient is being treated with ACEi
• Patient must have acute angioedema attack caused by ACEi
• Treatment should be administered within 10 hours after onset of the angioedema
• Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
• Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
• Signed patient information consent form

Exclusion Criteria:

• Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic edema, anaphylaxis, insect bite, trauma, abscess, local inflammation, local tumour, post-operative or post-radiogenic edema, salivary gland disorders
• Participation in a clinical study in the past 30 days
• Patients with simultaneous itchiness of skin (acute urticaria)
• Patients with a history of angioedema before taking ACEi
• History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
• Pregnancy and/or breastfeeding
• Mental retardation of the patient with restriction of general judgment and awareness
• History of drug abuse (including alcohol and alcoholic liver disorders)
• Potentially unreliable patients
• Patients who are not suitable for the study in the opinion of the investigator