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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01843530
Recruitment Status : Suspended
First Posted : April 30, 2013
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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.


Condition or disease Intervention/treatment Phase
Acute ACE-induced Angioedema Drug: Berinert Drug: Clemastin Drug: Cortisone acetate Drug: NaCl Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Study Start Date : November 2013
Actual Primary Completion Date : October 5, 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
Cortisone, Clemastin + BERINERT
Drug: Berinert
Drug: Clemastin
Drug: Cortisone acetate
Placebo Comparator: Group 2
Cortinsone, Clemastin + NaCl
Drug: Clemastin
Drug: Cortisone acetate
Drug: NaCl



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843530


Locations
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Germany
Kath. Klinikum Bochum, Med. Klinik III
Bochum, Germany, 44787
Ludwig-Maximilian-Universität
München, Germany, 81377
Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
München, Germany, 81675
Universitätsklinikum Ulm, HNO
Ulm, Germany, 89070
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Murat Bas, Dr. Klinikum rechts der Isar
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Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT01843530    
Other Study ID Numbers: BER-1272-0058-I
First Posted: April 30, 2013    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Angioedema
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cortisone
Anti-Inflammatory Agents