Trials / Terminated
TerminatedNCT04091113
Hereditary Angioedema Kininogen Assay
Hereditary Angioedema Kininogen Assay: A Multicenter, Epidemiological, Observational Study.
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 59 (actual)
- Sponsor
- CENTOGENE GmbH Rostock · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter epidemiological observational study aiming to explore the cleaved high-molecular weight kininogen (cHMWK) including identification and characterization of other metabolite/biomarkers in HAE type 1/2 patients
Detailed description
Hereditary angioedema (HAE) is a rare autosomal dominant genetic disorder characterized by recurrent tissue angioedema episodes, mainly caused by mutations in the SERPING1 gene that encodes C1 inhibitor (C1-INH), a protease involved in limiting bradykinin production. Low levels of C1-INH (HAE type 1) or dysfunctional C1-INH (HAE type 2) lead to bradykinin accumulation, resulting in capillary leakage and tissue swelling. High Molecular Weight Kininogen (HMWK) proteolysis, by active plasma kallikrein, results in bradykinin and cHMWK generation. The goal of this study is to explore the cHMWK concentrations in HAE type 1/2 patients, as a biomarker for this disease. The HAEKA study is performed in collaboration with Shire. Shire is a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Conditions
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2021-09-12
- Completion
- 2021-12-31
- First posted
- 2019-09-16
- Last updated
- 2022-03-10
Locations
7 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT04091113. Inclusion in this directory is not an endorsement.