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)
QUALANGIO
1 other identifier
observational
45
1 country
1
Brief Summary
This study aims to describe quality of life in hereditary or acquired non drug-related bradykinin-mediated angioedema patients, using validated questionnaires
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 27, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedApril 17, 2018
April 1, 2018
5 months
July 27, 2017
April 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dermatology Life Quality Index (DLQI)
Description of Quality of Life (QoL) using DLQI
6 months
Angioedema Quality of Life (AE-QoL) Questionnaire
Description of QoL using AE-QOL questionnnaire
6 months
Study Arms (1)
Quality of life questionnaires
Data will be collected retrospectively and prospectively.
Interventions
Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score
Eligibility Criteria
Hereditary or Acquired non drug-induced bradykinin-mediated angioedema patients
You may qualify if:
- 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)
You may not qualify if:
- Acquired angioedema with normal C1 inhibitor activity (former "drug-induced")
- Minor subjects
- Vulnerable subjects (under guardianship/curatorship/tutorship)
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Besançon
Besançon, 25000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2017
First Posted
August 7, 2017
Study Start
July 11, 2016
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
April 17, 2018
Record last verified: 2018-04