Study of Clinical, Biological Characteristics and Quality of Life of Patients With Hereditary or Acquired Non Drug-induced Bradykinin-mediated Angioedema, Monitored in Besançon's Partner Site Reference Center for Studies of Kinin-mediated Angioedema (CREAK)

NCT ID: NCT03240991

Last Updated: 2018-04-17

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

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-11

Study Completion Date

2016-12-01

Brief Summary

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This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires

Detailed Description

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Conditions

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Angioedema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Quality of life questionnaires

Data will be collected retrospectively and prospectively.

Quality of life

Intervention Type OTHER

Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score

Interventions

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Quality of life

Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinically documented angioedema due to C1 inhibitor deficiency, hereditary (type I et II) or acquired
* Clinically documented angioedema with normal C1 inhibitor activity (hereditary type III)

Exclusion Criteria

* Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
* Minor subjects
* Vulnerable subjects (under guardianship/curatorship/tutorship)
* Pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Besançon

Besançon, , France

Site Status

Countries

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France

Other Identifiers

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P/2016/302

Identifier Type: -

Identifier Source: org_study_id

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