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

Primary Purpose

Acute ACE-induced Angioedema

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Berinert
Clemastin
Cortisone acetate
NaCl
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute ACE-induced Angioedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kath. Klinikum Bochum, Med. Klinik III
  • Ludwig-Maximilian-Universität
  • Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
  • Universitätsklinikum Ulm, HNO

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1

Group 2

Arm Description

Cortisone, Clemastin + BERINERT

Cortinsone, Clemastin + NaCl

Outcomes

Primary Outcome Measures

time of resolution
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.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2013
Last Updated
October 20, 2020
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01843530
Brief Title
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Official Title
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute ACE-induced Angioedema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Cortisone, Clemastin + BERINERT
Arm Title
Group 2
Arm Type
Placebo Comparator
Arm Description
Cortinsone, Clemastin + NaCl
Intervention Type
Drug
Intervention Name(s)
Berinert
Intervention Type
Drug
Intervention Name(s)
Clemastin
Intervention Type
Drug
Intervention Name(s)
Cortisone acetate
Intervention Type
Drug
Intervention Name(s)
NaCl
Primary Outcome Measure Information:
Title
time of resolution
Description
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.
Time Frame
07/2013 until 12/2014

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat Bas, Dr.
Organizational Affiliation
Klinikum rechts der Isar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kath. Klinikum Bochum, Med. Klinik III
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Ludwig-Maximilian-Universität
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Ulm, HNO
City
Ulm
ZIP/Postal Code
89070
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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