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Hereditary Angioedema Kininogen Assay (HAEKA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04091113
Recruitment Status : Terminated (we will update quickly)
First Posted : September 16, 2019
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
CENTOGENE GmbH Rostock

Study Description
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Brief 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

Condition or disease
Hereditary Angioedema

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.

Study Design
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Study Type : Observational
Actual Enrollment : 59 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hereditary Angioedema Kininogen Assay: A Multicenter, Epidemiological, Observational Study.
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 12, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Participants with Hereditary Angioedema
Participants older than 18 years that are clinically diagnosed with Hereditary Angioedema type 1/2 and experienced ≥4 HAE attacks within last 12 month before the enrollment


Outcome Measures
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Primary Outcome Measures :
  1. Exploring the cleaved high-molecular weight kininogen (cHMWK) as a biomarker in HAE type 1/2 patients, as well as to study the differences between HAE type 1/2 patients without lanadelumab treatment versus patients on lanadelumab treatment. [ Time Frame: 30 months ]
    Samples from HAE patients without lanadelumab treatment versus patients on lanadelumab treatment will be analyzed for cHMWK via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS).


Secondary Outcome Measures :
  1. Studying cHMWK as a biomarker in HAE type 1/2 patients with edema attack, as well as to study the differences between HAE type 1/2 patients without lanadelumab treatment versus patients on lanadelumab treatment. [ Time Frame: 30 months ]
    Samples from HAE patients without lanadelumab treatment versus patients on lanadelumab treatment collected before/during/after angioedema attacks will be analyzed for cHMWK via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS).


Other Outcome Measures:
  1. Studying other metabolites as potential biomakers in HAE type 1/2 patients, as well as to study the differences between HAE type 1/2 patients without lanadelumab treatment versus patients on lanadelumab treatment. [ Time Frame: 30 months ]
    All samples will be analyzed for potential biomarker candidates via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS).


Biospecimen Retention:   Samples With DNA
Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hereditary Angioedema type 1/2 patients
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the participant
  • The patient with diagnosis of Hereditary Angioedema (HAE) type 1/2 based on international guidelines
  • The patient experienced ≥4 HAE attacks within last 12 month before enrolment in the study
  • The participant is older than 18 years old

Exclusion Criteria:

  • Inability to provide informed consent
  • The patient is not diagnosed with Hereditary Angioedema (HAE) type 1/2
  • The patient experienced ˂ 4 HAE attacks within last 12 month before enrolment in the study
  • The participant is younger than 18 years old
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091113


Locations
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Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany, 10117
Klinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Düsseldorf,
Düsseldorf, Germany, 40225
Klinikum der Johann-Wolfgang-Goethe-Universität
Frankfurt, Germany, 60596
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitäts-Hautklinik Leipzig
Leipzig, Germany, 04103
Hämophilie-Zentrum Rhein Main GmbH
Mörfelden-Walldorf, Germany, 64546
Universitätsklinikum Ulm
Ulm, Germany, 89075
Sponsors and Collaborators
CENTOGENE GmbH Rostock
Investigators
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Study Chair: Peter Bauer, MD Centogene GmbH
More Information
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Responsible Party: CENTOGENE GmbH Rostock
ClinicalTrials.gov Identifier: NCT04091113    
Other Study ID Numbers: HAEKA 01-2019
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CENTOGENE GmbH Rostock:
Hereditary Angioedema
Cleaved high-molecular weight kininogen
Hereditary Angioedema Type I
Hereditary Angioedema Type II
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes