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

October 20, 2020 updated by: Technical University of Munich

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bochum, Germany, 44787
        • Kath. Klinikum Bochum, Med. Klinik III
      • München, Germany, 81377
        • Ludwig-Maximilian-Universität
      • München, Germany, 81675
        • Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
      • Ulm, Germany, 89070
        • Universitätsklinikum Ulm, HNO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Berinert
Drug: Clemastin
Drug: Cortisone acetate
Placebo Comparator: Group 2
Cortinsone, Clemastin + NaCl
Drug: NaCl
Drug: Clemastin
Drug: Cortisone acetate

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

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Principal Investigator: Murat Bas, Dr., Klinikum Rechts der Isar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 5, 2018

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

April 26, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

April 30, 2013

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

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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