- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843530
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Bochum, Germany, 44787
- Kath. Klinikum Bochum, Med. Klinik III
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München, Germany, 81377
- Ludwig-Maximilian-Universität
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München, Germany, 81675
- Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
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Ulm, Germany, 89070
- Universitätsklinikum Ulm, HNO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
Cortisone, Clemastin + BERINERT
|
|
Placebo Comparator: Group 2
Cortinsone, Clemastin + NaCl
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of resolution
Time Frame: 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.
|
07/2013 until 12/2014
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murat Bas, Dr., Klinikum rechts der Isar
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BER-1272-0058-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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