Angiotensin Converting Enzyme Inhibitor (ACE) Induced AngioedemaBERINERTRandomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema

Phase 1

• Conditions: Angiotensin – Converting – Enzyme – Inhibitors (ACEi) are used in the treatment of several types of cardiovascular and renal diseases. A known side effect of ACEi are angioedema of the head and neck region. These can lead to severe dyspnoea and the need for intubation and are thought to be bradykinin mediated. Up until now there is no study-evaluated conservative therapeutic concept for the treatment of these patients.; MedDRA version: 18.1Level: HLTClassification code 10002425Term: AngioedemasSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-001670-28-DE
• Lead Sponsor: Medizinische Fakultät der Technischen Universität München

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-14
• Last Update Posted: 15 October 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 52

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 in at least one severity scale) 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

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 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic oedema, anaphylaxis, insect bite, trauma, abscess, local inflammation,
?local tumour, post-operative or post-radiogenic oedema, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified