Status:
COMPLETED
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Lead Sponsor:
Technical University of Munich
Conditions:
Acute ACE-induced Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is a randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema. This study should show that Berinert shortens the time to complet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01843530
Start Date
November 1 2013
End Date
September 30 2019
Last Update
November 24 2023
Active Locations (4)
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1
Kath. Klinikum Bochum, Med. Klinik III
Bochum, Germany, 44787
2
Ludwig-Maximilian-Universität
München, Germany, 81377
3
Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
München, Germany, 81675
4
Universitätsklinikum Ulm, HNO
Ulm, Germany, 89070