CLOUD-R HAE REGISTRY

Recruiting

• Conditions: ANGIOEDEMA

• Registration Number: NCT03845946
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.

Detailed Description

The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.

The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.

The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.

Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".

Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.

Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-29
• Last Update Posted: 2021-11-01
• Primary Completion: 2028-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Any patient with isolated angioedema without associated wheals.
• Patients with hereditary angioedema with or without C1 deficiency.
• Major patient with consent (signature)
• Minor patient whose parents / legal guardians have given their consent (signature)

Exclusion Criteria

• Patient unable to give consent.
• Wheals with angioedema

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic patient data	5 years	Sexe and age of patient
Comorbidity	5 years	additional diseases
Angioedema diagnosis	5 years	family history
Treatments used in the prophylaxis of angioedema	5 years	start date
Clinical characteristics	5 years	summary of patient visit report
Treatments used in managing the acute angioedema event	5 years	date and time of acute treatment
Duration and severity of acute angioedema events	5 years	need access to hospital

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, Isere, France