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NCT03240991 Clinical Trial

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)

Angioedema Clinical Trial

— QUALANGIO  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03240991
Other study ID # P/2016/302
Secondary ID
Status Completed
Phase
First received July 27, 2017
Last updated April 13, 2018
Start date July 11, 2016
Est. completion date December 1, 2016

Study information
Verified date April 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 1, 2016
Est. primary completion date December 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Quality of life
Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score

Locations
Country Name City State
France CHU Besançon Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dermatology Life Quality Index (DLQI) Description of Quality of Life (QoL) using DLQI 6 months
Primary Angioedema Quality of Life (AE-QoL) Questionnaire Description of QoL using AE-QOL questionnnaire 6 months
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