Determination of Specific Biomarkers of Acute Attack of Angioedema Within Pediatric Population

Terminated

• Conditions: Hereditary Angioedema; Healthy Volunteers
• Interventions: Other: blood sample

• Registration Number: NCT02854397
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

In emergency room, this is crucial to diagnose an acute attack of hereditary angioedema (HAE) to quickly provide the efficient treatment. Currently, there is no specific biomarker for acute attack of bradykinin-mediated angioedema to help clinicians for patient care. However, previous works are carried out for that purpose. All the potential candidate biomarkers must be validated in prospective studies to estimate their specificity and sensitivity values, and to understand their potential utility in patient care.

The main goal of this clinical trial is to estimate the diagnostic value of VE-cadherin in pediatric population, for the differential diagnosis between HAE crisis and angioedema resulting of mast cell activation crisis (the main differential diagnosis of HAE).

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-03
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-16
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

For HAE: patient with a documented diagnosis of HAE:

• type I (from an antigenic deficiency of the C1 esterase inhibitor) or type II (from a functional deficiency of the C1 esterase inhibitor). The existence of a mutation in SERPING1 was not necessary for the inclusion
• HAE with normal C1-INH (ex type III) with a required mutation in FXII gene or with a typical family history of HAE diagnosed by a specialized physician belonging to CREAK network.

For AE resulting of mast cell activation: a documented diagnosis of AE resulting of mast cell activation included:

• mastocytosis,
• chronic spontaneous urticaria,
• acute urticaria after exposure of allergen during allergy challenge tests,
• mast cell activation syndrome.

For the control group:

• composed of patients who presented a stabilized disease (that was not infectious, not auto-inflammatory or inflammatory disease and without implication of endothelial cells).

Exclusion Criteria

• Over 18 years or under 1 year.
• Diagnosis of HAE with a normal C1 esterase inhibitor or AE of unknown aetiology.
• Patients with HAE who received an acute attack treatment before the blood sample (the C1 esterase inhibitor concentrate or a bradykinin B2 receptor antagonist); patients with HAE who received a prophylactic treatment (danazol).
• Patients who were treated by omalizumab or corticosteroid treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy patients, without angioedema	blood sample	A quantity of additional blood was taken from eligible patients who had a scheduled blood sample.
patients with hereditary angioedema	blood sample	A blood sample will be performed in crisis and 7 days after the crisis.
patients with angioedema resulting of mast cell activation	blood sample	A blood sample will be performed in crisis and 7 days after the crisis.

Primary Outcome Measures

Name	Time	Method
VE-cadherin level	Half a day	For the diagnosis of acute attack of hereditary angioedema

Secondary Outcome Measures

Name	Time	Method
Dosage of Fc KHPM	Half a day	Analysis of the cleaved fragments from high molecular weight kininogen
Dosage of VE-cadherin (vascular endothelial)	Half a day	Analysis of the cleaved fragments from high molecular weight kininogen
Dosage of D-dimer	Half a day	Analysis of the cleaved fragments from high molecular weight kininogen
Dosage of Tryptase	Half a day	Analysis of the cleaved fragments from high molecular weight kininogen

Trial Locations

Locations (14)

General Hospital; 🇫🇷 Niort, France

University hospital Toulouse; 🇫🇷 Toulouse, France

University hospital Nancy; 🇫🇷 Nancy, France

University Hospital Lyon; 🇫🇷 Lyon, France

University hopital Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

University Hospital Grenoble; 🇫🇷 Grenoble, France

University hospital Rouen; 🇫🇷 Rouen, France

University hospital angers; 🇫🇷 Angers, France

University Hospital Besançon; 🇫🇷 Besançon, France

University hospital Bordeaux; 🇫🇷 Bordeaux, France

University Hospital Lille; 🇫🇷 Lille, France

University hospital Marseille; 🇫🇷 Marseille, France

University hospital Montpellier; 🇫🇷 Montpellier, France

university hospital Saint-Antoine (AP-HP); 🇫🇷 Paris, France