Epidemiological Analysis for Hereditary Angioedema Disease
EHA
1 other identifier
observational
2,318
6 countries
35
Brief Summary
An international, multicenter, epidemiological, observational study investigating the prevalence of Hereditary Angioedema (HAE) disease among participants with recurrent episodes of abdominal pain of no obvious etiology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
Typical duration for all trials
35 active sites
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
First Submitted
Initial submission to the registry
June 5, 2018
CompletedFirst Posted
Study publicly available on registry
June 15, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2022
CompletedApril 25, 2022
April 1, 2022
3.6 years
June 5, 2018
April 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Epidemiological analysis of prevalence of the HAE in participants with previous episodes of abdominal pain of no obvious etiology.
Dry Blood Spot (DBS)-based biochemical measurements of C4 complement and the protease C1 inhibitor levels will be analyzed via liquid chromatography multiple reaction. The pathological biochemical results will be genetically validated via combination of the Next-Generation Sequencing (the mutation will be confirmed by Sanger sequencing) and Multiplex ligation-dependent probe amplification of SERPING1.
4 years
Secondary Outcomes (1)
Establishment of a biomarker in HAE-positive cohort
4 years
Study Arms (1)
Participants with abdominal pain attacks
Participants experiencing recurrent abdominal pain attacks without a clear etiolgy aged between 2-60 years
Eligibility Criteria
Participants with previous episodes of abdominal pain attacks of no obvious etiology
You may qualify if:
- Informed consent will be obtained from the participant or the parent or legal guardian
- Participants with previous episodes of abdominal pain of no obvious etiology
- Participants aged between 2 to 60 years old
You may not qualify if:
- Previous diagnosis of HAE
- Inability to provide informed consent
- The etiology of abdominal pain attacks is determined
- Participants that are younger than 2 years old or older than 60 years old
- Previous enrolled in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Praxis und Tagesklinik Prof. Dr. med. Jens Papke
Neustadt, Saxony, 01844, Germany
Universitätsklinikum Düsseldorf, Klinik für Allgemein-, Viszeral- und Kinderchirurgie
Düsseldorf, 40225, Germany
Dr. med. Engelhard | Dr. med. Wihl, Internistische Gemeinschaftspraxis
Frankenberg, 35066, Germany
Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
Greifswald, 17475, Germany
Klinikum Kassel GmbH
Kassel, 34125, Germany
Universitätsklinikum Leipzig AöR
Leipzig, 04103, Germany
Johannes Wesling Klinikum Minden, Universitätsklinik der Ruhr Universität Bochum
Minden, 32429, Germany
Kinder- und Jugendklinik, Universitätsmedizin Rostock
Rostock, 18057, Germany
Azienda Ospedaliera Antonio Cardarelli
Napoli, 80131, Italy
Hiroshima University Graduate School of Biomedical Sciences
Hiroshima, 7348551, Japan
Gastromed
Bialystok, 15-322, Poland
Centrum Medyczne Alfamedica Silesia North
Częstochowa, 42218, Poland
Specialized Medical Offices MeaMedica
Gdansk, 80-244, Poland
Przychodnia Polskiej Fundacji Gastroenterologii
Warsaw, 00-631, Poland
WIP Warsaw IBD Point
Warsaw, 00-728, Poland
Przychodnia Lekarska MediSpace
Warsaw, 1044, Poland
Uniwersytecki Szpital Kliniczny
Wroclaw, 50-556, Poland
Cdl "Barska"
Włocławek, 87 - 800, Poland
Cukurova University Balcali Hospital
Adana, 01330, Turkey (Türkiye)
Bezmialem Vakif Üniversitesi
Istanbul, 34093, Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylül University Research and Application Hospital
Izmir, 35330, Turkey (Türkiye)
Aberdeen Royal Infirmary
Aberdeen, AB252ZN, United Kingdom
University Hospital of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G514TF, United Kingdom
Royal Alexandra Hospital
Glasgow, PA29PN, United Kingdom
University Hospital Crosshouse
Kilmarnock, KA20BE, United Kingdom
University Hospital Leicester (UHL)
Leicester, LE1 5WW, United Kingdom
The Royal London Hospital
London, E1 1BB, United Kingdom
St Thomas Hospital
London, SE1 7EH, United Kingdom
St George's University Hospital London
London, SW17 0RE, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
Milton Keynes Hospital
Milton Keynes, MK6 5LD, United Kingdom
Biospecimen
Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Bauer, MD
CENTOGENE GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2018
First Posted
June 15, 2018
Study Start
September 1, 2018
Primary Completion
April 11, 2022
Study Completion
April 11, 2022
Last Updated
April 25, 2022
Record last verified: 2022-04