NCT01843530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Longer than P75 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

4.9 years

First QC Date

April 26, 2013

Last Update Submit

November 22, 2023

Conditions

Acute ACE-induced Angioedema

Outcome Measures

Primary Outcomes (1)

  • 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.

    07/2013 until 12/2014

Study Arms (2)

Group 1

EXPERIMENTAL

Cortisone, Clemastin + BERINERT

Drug: BerinertDrug: ClemastinDrug: Cortisone acetate

Group 2

PLACEBO COMPARATOR

Cortinsone, Clemastin + NaCl

Drug: ClemastinDrug: Cortisone acetateDrug: NaCl

Interventions

BerinertDRUG
Group 1
ClemastinDRUG
Group 1Group 2
Cortisone acetateDRUG
Group 1Group 2
NaClDRUG
Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kath. Klinikum Bochum, Med. Klinik III

Bochum, 44787, Germany

Location

Ludwig-Maximilian-Universität

München, 81377, Germany

Location

Klinikum rechts der Isar, Hals-Nasen-Ohren Klinik

München, 81675, Germany

Location

Universitätsklinikum Ulm, HNO

Ulm, 89070, Germany

Location

MeSH Terms

Interventions

Complement C1 Inhibitor ProteinCortisone

Intervention Hierarchy (Ancestors)

GlycoproteinsGlycoconjugatesCarbohydratesComplement C1 Inactivator ProteinsSerpinsPeptidesAmino Acids, Peptides, and ProteinsComplement Inactivator ProteinsComplement System ProteinsImmunoproteinsBlood ProteinsProteinsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds17-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Murat Bas, Dr.

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

November 1, 2013

Primary Completion

October 5, 2018

Study Completion

September 30, 2019

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

DE(4)