AngioedemaNCT06210698
Angioedema Biomarker Research Study
An observational study of Angioedema and Angioedemas, Hereditary, run by Foundation For Rare Disease Research at 1 site in United States.
Trial summary
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Angioedema, Angioedemas, Hereditary, Urticaria
- What is being tested?
- Venipuncture
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The collection of medical history and peripheral blood (venipuncture) to perform multiple diagnostic assays from patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Healthy volunteers will not have a medical history of angioedema.
Who may be able to join
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
Who cannot join
- Minor: 11 years of age or younger.
- Cannot read or understand the informed consent form and instructions.
- Unable to perform the peripheral blood sample collection.
- Taking medications contraindicated for testing.
- History of excessive bleeding after phlebotomy, e.g. Hemophilia.
- Contraindication due to other health-related issues.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Asthma and Allergy Clinical Research
Wheaton, Maryland, 20902
Lili Wan, PhD
Henry LI, MD
About this study
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.
Read the detailed description
Purpose: The purpose of this prospective non-interventional non-randomized diagnostic study is to first identify patients with recurrent angioedema attacks, then collect their blood samples (venipuncture) and ultimately send the samples to specialized laboratories to perform multiple diagnostic assays, novel and traditional, that can distinguish the various forms of angioedema (urticaria and non-urticarial symptoms and signs), and healthy subjects.
Methods and Materials: Blood specimen collection from a total of 300 patients with recurrent angioedema attacks, and 300 healthy volunteers without a history of angioedema attacks. Laboratory testing will include assays on multiple platforms. Complement testing via immunoassay and biochemistry techniques. Flow Cytometry using multiple markers. Mass Spectrometry that includes bradykinin metabolite and histamine detection. Molecular Genetics include Sanger sequencing, Next Generation Sequencing (NGS), and digital PCR.
Patient population: Study participants to be screened who have a history of recurrent angioedema incidents as well as a population of healthy subjects. A medical history will be documented after obtaining informed patient consent to enter into the clinical trial. Each enrolled participant will have blood collected as whole blood, plasma and serum via venipuncture.
Eligibility criteria (inclusion) for sample collection (angioedema subject):
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
Eligibility criteria (inclusion) for sample collection (for healthy participant/subject):
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- No history of any angioedema symptoms and signs, previous laboratory diagnostic testing, or genetically proven cases.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
- Not on ACE inhibitors and if on blood pressure medication, to indicate the drug(s).
Exclusion Criteria (for all participants):
- Minor: 11 years of age or younger.
- Cannot read or understand the informed consent form and instructions.
- Unable to perform the peripheral blood sample collection.
- Taking medications contraindicated for testing.
- History of excessive bleeding after phlebotomy, e.g. Hemophilia.
- Contraindication due to other health-related issues.
- Conditions
- Angioedema, Angioedemas, Hereditary, Urticaria, Mastocytosis, ACE Inhibitor-Induced Angioedema, C1 Inhibitor Deficiency
- Being tested
- Venipuncture
- Keywords
- angioedema, c1-inhibitor deficiency, C1-inhibitor dysfunction, hereditary angioedema, HAE, ACE Inhibitor-induced angioedema, serum tryptase, mastocytosis, systemic mastocytosis, indolent systemic mastocytosis
- Medical subject headings
- Angioedema, Angioedemas, Hereditary, Urticaria, Mastocytosis, Mastocytosis, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenipunctureDiagnostic test
venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Recurrent Angioedema | Broad definition: Angioedema due to urticaria (histaminergic/mast-cell) or non-urticarial (non-histaminergic) etiology Narrow definition: non-urticarial angioedema - distinguishing between C1-Inhibitor deficiency/dysfunction, and Angioedema with normal levels of C1-Inhibitor. Receives: Diagnostic Test: Venipuncture | |
| Healthy Subjects | Broad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema) Receives: Diagnostic Test: Venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Novel versus traditional diagnostic blood test for angioedema
Determining whether novel test methods can be more efficient than currently available or traditional laboratory test for angioedema diagnosis
Measured: 2 years
Secondary outcomes (4)
Genetic analysis of angioedema versus non-angioedema affected populations
Genetic testing that include know angioedema mutations, such as SERPING1
Measured: 2 years
Development of novel Bradykinin biomarkers
Mass Spectrometry analysis of plasma for bradykinin metabolites
Measured: 2 years
Immunoassay laboratory developed tests for angioedema
development of novel immunoassay biomarkers, such as the detection of cleaved HMWK
Measured: 2 years
Lymphocyte profile studies
Determine whether the immune system has a role in angioedema attacks
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start15 Jan 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngioedemaStudies 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation For Rare Disease Research
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Asthma & Allergy, Virant Diagnostics, Inc., MedBio Reference Laboratories, Inc.
- Responsible party
- Sponsor
- Investigators
- Lili Wan, PhD, Study director, Institute for Asthma & Allergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210698
- Sponsor's protocol ID
- Virant-A001
- Status last verified
- Aug 2026
- First submitted
- 8 Jan 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The analyzed data will be published in a peer-reviewed journal and preliminary results published on clinicaltrials.gov website
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angioedema Biomarker Research Study
- ClinicalTrials.gov ID
- NCT06210698
- Acronym / sponsor ID
- Virant-A001
- Conditions
- Angioedema, Angioedemas, Hereditary, Urticaria, Mastocytosis, ACE Inhibitor-Induced Angioedema, C1 Inhibitor Deficiency
- Keywords
- angioedema, c1-inhibitor deficiency, C1-inhibitor dysfunction, hereditary angioedema, HAE, ACE Inhibitor-induced angioedema, serum tryptase, mastocytosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Foundation For Rare Disease ResearchUniversity, hospital or other
- Collaborators
- Institute for Asthma & Allergy, Virant Diagnostics, Inc., MedBio Reference Laboratories, Inc.
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 18 Jan 2024 (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.
This clinical trial aims to evaluate and compare novel and commercially available diagnostic assays through blood tests for the differential diagnosis and comprehensive assessment of patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. The primary objective is to assess the efficiency of novel diagnostic assays, both individually and in combination, in comparison to currently available commercial tests. The ultimate goal is to establish the feasibility of developing an affordable and accurate laboratory test capable of diagnosing the diverse etiological manifestations of angioedema.
Detailed description
Purpose: The purpose of this prospective non-interventional non-randomized diagnostic study is to first identify patients with recurrent angioedema attacks, then collect their blood samples (venipuncture) and ultimately send the samples to specialized laboratories to perform multiple diagnostic assays, novel and traditional, that can distinguish the various forms of angioedema (urticaria and non-urticarial symptoms and signs), and healthy subjects.
Methods and Materials: Blood specimen collection from a total of 300 patients with recurrent angioedema attacks, and 300 healthy volunteers without a history of angioedema attacks. Laboratory testing will include assays on multiple platforms. Complement testing via immunoassay and biochemistry techniques. Flow Cytometry using multiple markers. Mass Spectrometry that includes bradykinin metabolite and histamine detection. Molecular Genetics include Sanger sequencing, Next Generation Sequencing (NGS), and digital PCR.
Patient population: Study participants to be screened who have a history of recurrent angioedema incidents as well as a population of healthy subjects. A medical history will be documented after obtaining informed patient consent to enter into the clinical trial. Each enrolled participant will have blood collected as whole blood, plasma and serum via venipuncture.
Eligibility criteria (inclusion) for sample collection (angioedema subject):
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
Eligibility criteria (inclusion) for sample collection (for healthy participant/subject):
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- No history of any angioedema symptoms and signs, previous laboratory diagnostic testing, or genetically proven cases.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
- Not on ACE inhibitors and if on blood pressure medication, to indicate the drug(s).
Exclusion Criteria (for all participants):
- Minor: 11 years of age or younger.
- Cannot read or understand the informed consent form and instructions.
- Unable to perform the peripheral blood sample collection.
- Taking medications contraindicated for testing.
- History of excessive bleeding after phlebotomy, e.g. Hemophilia.
- Contraindication due to other health-related issues.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recurrent Angioedema | – | Diagnostic Test: VenipunctureBroad definition: Angioedema due to urticaria (histaminergic/mast-cell) or non-urticarial (non-histaminergic) etiology Narrow definition: non-urticarial angioedema - distinguishing between C1-Inhibitor deficiency/dysfunction, and Angioedema with normal levels of C1-Inhibitor. |
| Healthy Subjects | – | Diagnostic Test: VenipunctureBroad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema) |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The collection of medical history and peripheral blood (venipuncture) to perform multiple diagnostic assays from patients experiencing recurrent angioedema attacks, including both urticarial and non-urticarial angioedema. Healthy volunteers will not have a medical history of angioedema.
Key inclusion criteria (4 listed)
- Understand and sign the informed consent form before starting any study procedure.
- Adult or Child: aged 12 years of age or older (consent must be signed by a single parent or legal guardian).
- Angioedema symptoms and signs by medical history, or previous laboratory diagnostic testing, or genetically proven cases (e.g. SERPING1 or other mutation). Patients can be on active medication for the treatment and prophylaxis of angioedema. Angioedema cases must be verified by a clinician from IAA.
- Able to perform and endure safely the collection of peripheral blood samples (venipuncture), or optionally agree to have additional testing via a skin punch biopsy.
Key exclusion criteria (6 listed)
- Minor: 11 years of age or younger.
- Cannot read or understand the informed consent form and instructions.
- Unable to perform the peripheral blood sample collection.
- Taking medications contraindicated for testing.
- History of excessive bleeding after phlebotomy, e.g. Hemophilia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venipuncturevenipuncture | Diagnostic test | Healthy Subjects, Recurrent Angioedema |
Primary outcome
Novel versus traditional diagnostic blood test for angioedema
Time frame: 2 years
Determining whether novel test methods can be more efficient than currently available or traditional laboratory test for angioedema diagnosis
4 secondary outcomes
Genetic analysis of angioedema versus non-angioedema affected populations
Time frame: 2 years
Development of novel Bradykinin biomarkers
Time frame: 2 years
Immunoassay laboratory developed tests for angioedema
Time frame: 2 years
Lymphocyte profile studies
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The analyzed data will be published in a peer-reviewed journal and preliminary results published on clinicaltrials.gov website
Related trials for Angioedema
RecruitingObservational study
A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea
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Active, not recruitingPhase 3
HAELO: A Phase 3 Study to Evaluate NTLA-2002 in Participants With Hereditary Angioedema (HAE)
Hereditary Angioedema
RecruitingPhase 3
Study of IV Human Plasma-derived C1 Esterase Inhibitor Concentrate in Patients With Congenital C1-INH Deficiency for Treatment and Pre-procedure Preventing of Acute Hereditary Angioedema Attacks
Acute Hereditary Angio Edema
Active, not recruitingPhase 1/2
NTLA-2002 in Adults With Hereditary Angioedema (HAE)
Hereditary Angioedema
Enrolling by invitationPhase 3
Long-Term, Open-label Study of Oral Deucrictibant Extended-Release Tablet for Prophylaxis Against Angioedema Attacks in Adolescents and Adults With HAE
Hereditary Angioedema (HAE)
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.
Lili Wan, PhD study director
Institute for Asthma & Allergy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Angioedema and Angioedemas, Hereditary, run by Foundation For Rare Disease Research at 1 site in United States.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Henry Li, MD, PhD (877-888-2973 ext. 100, henryli@allergyasthma.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Novel versus traditional diagnostic blood test for angioedema (time frame: 2 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 24 Aug 2026.