Recruiting

Diagnostic Assays

Sponsor:

Foundation For Rare Disease Research

Code:

NCT06210698

Conditions

Angioedema

Angioedemas, Hereditary

Urticaria

Mastocytosis

ACE Inhibitor-Induced Angioedema

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Interventions

Venipuncture

Study Details

Brief 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. 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.

Conditions

Angioedema

Angioedemas, Hereditary

Urticaria

Mastocytosis

ACE Inhibitor-Induced Angioedema

Study ID

NCT06210698

Start date

Jan 15, 2024

Status verified date

Aug, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Healthy Subjects

Broad definition: No medical history of angioedema of any kind, including urticaria (histaminergic) or drug-induced angioedema (e.g. ACE-Inhibitor angioedema)

Interventions

Venipuncture

venipuncture

Primary outcome measure

  • Novel versus traditional diagnostic blood test for angioedema [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Henry Li, MD, PhD

877-888-2973henryli@allergyasthma.us

Joseph Chiao, MD

8778882973Jchiao@virantdx.com

Locations

Institute for Asthma and Allergy Clinical Research

Recruiting

Wheaton, Maryland, United States, 20902

Principal Investigator:

Henry LI, MD

More Information

Sponsor

Foundation For Rare Disease Research

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • angioedema
  • c1-inhibitor deficiency
  • C1-inhibitor dysfunction
  • hereditary angioedema
  • HAE
  • ACE Inhibitor-induced angioedema
  • serum tryptase
  • mastocytosis
  • systemic mastocytosis
  • indolent systemic mastocytosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foundation For Rare Disease Research on 2026-08-24.