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

NCT ID: NCT01843530

Last Updated: 2023-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2019-09-30

Brief Summary

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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

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Conditions

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Acute ACE-induced Angioedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1

Cortisone, Clemastin + BERINERT

Group Type EXPERIMENTAL

Berinert

Intervention Type DRUG

Clemastin

Intervention Type DRUG

Cortisone acetate

Intervention Type DRUG

Group 2

Cortinsone, Clemastin + NaCl

Group Type PLACEBO_COMPARATOR

Clemastin

Intervention Type DRUG

Cortisone acetate

Intervention Type DRUG

NaCl

Intervention Type DRUG

Interventions

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Berinert

Intervention Type DRUG

Clemastin

Intervention Type DRUG

Cortisone acetate

Intervention Type DRUG

NaCl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Murat Bas, Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar

Locations

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Kath. Klinikum Bochum, Med. Klinik III

Bochum, , Germany

Site Status

Ludwig-Maximilian-Universität

München, , Germany

Site Status

Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik

München, , Germany

Site Status

Universitätsklinikum Ulm, HNO

Ulm, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BER-1272-0058-I

Identifier Type: -

Identifier Source: org_study_id