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Hereditary Angioedema Kininogen Assay (HAEKA)

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ClinicalTrials.gov Identifier: NCT04091113
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
CENTOGENE GmbH Rostock

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.

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Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


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



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®)


Information from the National Library of Medicine

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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

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


Contacts
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Contact: Selen Zülbahar, PhD +49 (0)38180113431 Selen.Zuelbahar@centogene.com

Locations
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Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 10117
Contact: Markus Magerl, MD    +49 (0)30450518318    markus.magerl@charite.de   
Principal Investigator: Markus Magerl, MD         
Klinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Düsseldorf, Recruiting
Düsseldorf, Germany, 40225
Contact: Martin Wagenmann, MD    +49 2118117570    martin.wagenmann@uni-duesseldorf.de   
Principal Investigator: Martin Wagenmann, MD         
Klinikum der Johann-Wolfgang-Goethe-Universität Recruiting
Frankfurt, Germany, 60596
Contact: Emel Aygören-Pürsün, MD    +49 (0)6963016312    aygoeren@em.uni-frankfurt.de   
Principal Investigator: Emel Aygören-Pürsün, MD         
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Bettina Wedi, MD    +49 (0)5115327652    wedi.bettina@mh-hannover.de   
Principal Investigator: Bettina Wedi, MD         
Universitäts-Hautklinik Leipzig Recruiting
Leipzig, Germany, 04103
Contact: Regina Treudler, MD    +49 (0)3419718690    regina.treudler@uniklinik-leipzig.de   
Principal Investigator: Regina Treudler, MD         
Hämophilie-Zentrum Rhein Main GmbH Recruiting
Mörfelden-Walldorf, Germany, 64546
Contact: Inmaculada Martinez-Saguer, MD    +49 6105 9638900    inmaculada.martinez@hzrm.de   
Principal Investigator: Inmaculada Martinez-Saguer, MD         
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89075
Contact: Jens Greve, MD    +49 (0)73150059501    Jens.Greve@uniklinik-ulm.de   
Principal Investigator: Jens Greve, MD         
Sponsors and Collaborators
CENTOGENE GmbH Rostock
Investigators
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Study Chair: Peter Bauer, MD Centogene GmbH
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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: April 9, 2021
Last Verified: March 2021
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
Genetic Diseases, Inborn