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

Phase 3

Completed

• Conditions: Acute ACE-induced Angioedema
• Interventions: Drug: Berinert; Drug: Cortisone acetate; Drug: Clemastin; Drug: NaCl

• Registration Number: NCT01843530
• Lead Sponsor: Technical University of Munich

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 complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment. This study should also compare the time to onset of relief as defined by an at least one point reduction on the severity scale of ACE-induced angioedema with Berinert versus placebo.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-26
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-04-30
• Study Start: 2013-11
• Primary Completion: 2018-10-05
• Study Completion: 2019-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Berinert	Cortisone, Clemastin + BERINERT
Group 2	Cortisone acetate	Cortinsone, Clemastin + NaCl
Group 1	Clemastin	Cortisone, Clemastin + BERINERT
Group 2	Clemastin	Cortinsone, Clemastin + NaCl
Group 2	NaCl	Cortinsone, Clemastin + NaCl
Group 1	Cortisone acetate	Cortisone, Clemastin + BERINERT

Primary Outcome Measures

Name	Time	Method
time of resolution	07/2013 until 12/2014	Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top of standard treatment.

Trial Locations

Locations (4)

Kath. Klinikum Bochum, Med. Klinik III; 🇩🇪 Bochum, Germany

Ludwig-Maximilian-Universität; 🇩🇪 München, Germany

Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik; 🇩🇪 München, Germany

Universitätsklinikum Ulm, HNO; 🇩🇪 Ulm, Germany