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CLOUD-R HAE REGISTRY

NCT ID: NCT03845946

Last Updated: 2021-11-01

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2028-09-01

Brief Summary

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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

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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.

Conditions

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ANGIOEDEMA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hereditary angioedema type I/II

Hereditary angioedema with C1Inh deficiency

angioedema

Intervention Type BEHAVIORAL

electronic tracking book

Acquired angioedema

Angioedema with acquired C1Inh deficiency

angioedema

Intervention Type BEHAVIORAL

electronic tracking book

Drug induced angioedema

Angioedema associated with ACEi used

angioedema

Intervention Type BEHAVIORAL

electronic tracking book

Mast cell induced angioedema

Spontaneous mast cell induced isolated angioedema

angioedema

Intervention Type BEHAVIORAL

electronic tracking book

Hereditary angioedema with nC1Inh

Hereditary angioedema with normal C1Inh and with F12, PLG, ANGPT2 mutations

angioedema

Intervention Type BEHAVIORAL

electronic tracking book

Interventions

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angioedema

electronic tracking book

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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laurence bouillet

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital Grenoble

Grenoble, Isere, France

Site Status RECRUITING

Countries

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France

Central Contacts

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laurence bouilelt, MD, PhD

Role: CONTACT

Phone: +33476765565

Email: [email protected]

Isabelle Boccon-Gibod

Role: CONTACT

Phone: +3347676767640

Email: [email protected]

Facility Contacts

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Laurence Bouillet, MD, PhD

Role: primary

Other Identifiers

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38RC17.187

Identifier Type: -

Identifier Source: org_study_id