Abdominal PainEHANCT03558009
Epidemiological Analysis for Hereditary Angioedema Disease
An observational study of Abdominal Pain and Functional Abdominal Pain, run by CENTOGENE GmbH Rostock at 35 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- Abdominal Pain, Functional Abdominal Pain
- How many people
- 2,318 participants
- Where
- 35 sitesin 6 countries
- Study dates
- 1 Sep 2018to 11 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Participants with previous episodes of abdominal pain attacks of no obvious etiology
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 6 countries.
35 sites in 6 countries
United Kingdom13 sites
Aberdeen Royal Infirmary
Aberdeen, AB252ZN
University Hospital of Derby and Burton NHS Foundation Trust
Derby, DE22 3NE
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
Queen Elizabeth University Hospital
Glasgow, G514TF
Royal Alexandra Hospital
Glasgow, PA29PN
University Hospital Crosshouse
Kilmarnock, KA20BE
University Hospital Leicester (UHL)
Leicester, LE1 5WW
The Royal London Hospital
London, E1 1BB
St Thomas Hospital
London, SE1 7EH
St George's University Hospital London
London, SW17 0RE
Imperial College Healthcare NHS Trust
London, W12 0HS
Manchester Royal Infirmary
Manchester, M13 9WL
Milton Keynes Hospital
Milton Keynes, MK6 5LD
Germany8 sites
Universitätsklinikum Düsseldorf, Klinik für Allgemein-, Viszeral- und Kinderchirurgie
Düsseldorf, 40225
Dr. med. Engelhard | Dr. med. Wihl, Internistische Gemeinschaftspraxis
Frankenberg, 35066
Universitätsmedizin Greifswald Körperschaft des öffentlichen Rechts
Greifswald, 17475
Klinikum Kassel GmbH
Kassel, 34125
Universitätsklinikum Leipzig AöR
Leipzig, 04103
Johannes Wesling Klinikum Minden, Universitätsklinik der Ruhr Universität Bochum
Minden, 32429
Praxis und Tagesklinik Prof. Dr. med. Jens Papke
Neustadt, Saxony, 01844
Kinder- und Jugendklinik, Universitätsmedizin Rostock
Rostock, 18057
Poland8 sites
Gastromed
Bialystok, 15-322
Centrum Medyczne Alfamedica Silesia North
Częstochowa, 42218
Specialized Medical Offices MeaMedica
Gdansk, 80-244
Przychodnia Polskiej Fundacji Gastroenterologii
Warsaw, 00-631
WIP Warsaw IBD Point
Warsaw, 00-728
Przychodnia Lekarska MediSpace
Warsaw, 1044
Cdl "Barska"
Włocławek, 87 - 800
Uniwersytecki Szpital Kliniczny
Wroclaw, 50-556
Turkey (Türkiye)4 sites
Cukurova University Balcali Hospital
Adana, 01330
Bezmialem Vakif Üniversitesi
Istanbul, 34093
Ege University Faculty of Medicine
Izmir, 35100
Dokuz Eylül University Research and Application Hospital
Izmir, 35330
Japan1 site
Hiroshima University Graduate School of Biomedical Sciences
Hiroshima, 7348551
About this study
Official title: Epidemiological Analysis for Hereditary Angioedema Disease: An International, Multicenter, Epidemiological Protocol
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.
Read the detailed description
Hereditary Angioedema (HAE) is a rare autosomal dominant disorder characterized most commonly by deficient (type 1) or nonfunctional (type 2) C1 inhibitor protein (encoded by SERPING1 gene). The disorder is associated with episodes of angioedema of the face, larynx, lips, abdomen, and extremities. The angioedema is caused by the activation of the kallikrein-kinin system that leads to the release of vasoactive peptides, followed by edema, which in severe cases can be life threatening.
Gastrointestinal involvement occurs in 93% of patients with HAE and may be the only manifestation of the disease. However, individuals with gastrointestinal symptoms are rarely considered for HAE and the disease can be misdiagnosed for several years.
EHA study focuses on the gastrointestinal complications of HAE as a potential area of misdiagnosis leading to surgical morbidity. Aim of the study is to investigate the prevalence of HAE among participants experiencing recurrent abdominal pain attacks with no clear etiology. The HAE-positive samples in the study will be further analyzed biochemically to identify disease-specific biomarker that may support the development of new diagnostic tools for HAE disease.
- Conditions
- Abdominal Pain, Functional Abdominal Pain
- Keywords
- Hereditary Angioedema, DBS-based biochemical and genetic assay for HAE type I/II, Biomarker
- Medical subject headings
- Abdominal Pain, Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with abdominal pain attacks | Participants experiencing recurrent abdominal pain attacks without a clear etiolgy aged between 2-60 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (1)
Establishment of a biomarker in HAE-positive cohort
HAE-positive samples will be analyzed for the identification of potential biomarkers (based on MS/MS-Tandem spectroscopy) and compared with the merged control samples in order establish a HAE specific biomarker.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Sep 2018
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,318 participants (actual)
Sponsor and investigators
- Lead sponsor
- CENTOGENE GmbH Rostock
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Bauer, MD, Study chair, CENTOGENE GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558009
- Sponsor's protocol ID
- EHA 01-2018
- Acronym
- EHA
- Status last verified
- Apr 2022
- First submitted
- 5 Jun 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Analysis for Hereditary Angioedema Disease: An International, Multicenter, Epidemiological Protocol
- ClinicalTrials.gov ID
- NCT03558009
- Acronym / sponsor ID
- EHA / EHA 01-2018
- Conditions
- Abdominal Pain, Functional Abdominal Pain
- Keywords
- Hereditary Angioedema, DBS-based biochemical and genetic assay for HAE type I/II, Biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,318 participants (actual)
- Lead sponsor
- CENTOGENE GmbH RostockIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hereditary Angioedema (HAE) is a rare autosomal dominant disorder characterized most commonly by deficient (type 1) or nonfunctional (type 2) C1 inhibitor protein (encoded by SERPING1 gene). The disorder is associated with episodes of angioedema of the face, larynx, lips, abdomen, and extremities. The angioedema is caused by the activation of the kallikrein-kinin system that leads to the release of vasoactive peptides, followed by edema, which in severe cases can be life threatening.
Gastrointestinal involvement occurs in 93% of patients with HAE and may be the only manifestation of the disease. However, individuals with gastrointestinal symptoms are rarely considered for HAE and the disease can be misdiagnosed for several years.
EHA study focuses on the gastrointestinal complications of HAE as a potential area of misdiagnosis leading to surgical morbidity. Aim of the study is to investigate the prevalence of HAE among participants experiencing recurrent abdominal pain attacks with no clear etiology. The HAE-positive samples in the study will be further analyzed biochemically to identify disease-specific biomarker that may support the development of new diagnostic tools for HAE disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with abdominal pain attacks | – | –Participants experiencing recurrent abdominal pain attacks without a clear etiolgy aged between 2-60 years |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Participants with previous episodes of abdominal pain attacks of no obvious etiology
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Epidemiological analysis of prevalence of the HAE in participants with previous episodes of abdominal pain of no obvious etiology.
Time frame: 4 years
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.
1 secondary outcome
Establishment of a biomarker in HAE-positive cohort
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bauer, MD study chair
CENTOGENE GmbH
35 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain and Functional Abdominal Pain, run by CENTOGENE GmbH Rostock at 35 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United Kingdom, Germany, Poland, Turkey (Türkiye), Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological analysis of prevalence of the HAE in participants with previous episodes of abdominal pain of no obvious etiology. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.