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Hereditary Angioedema Kininogen Assay (HAEKA)

HAEKA Study is a multicenter, epidemiological, observational study with the goal of identifying HAE specific biomarkers among patients in Germany.

  1. Hereditary Angioedema Kininogen Assay (HAEKA)

Summary and Rationale

Overview

HAEKA Study is a German-wide observational study focusing on patients with Hereditary Angioedema (HAE) – type 1 and 2. The goal of the study is to explore the cleaved high-molecular weight kininogen (cHMWK), including identification and characterization of other metabolite/biomarker levels in patients without lanadelumab treatment versus patients on lanadelumab treatment. Ultimately, this could allow for earlier diagnoses of disease and the ability to predict attacks in order to better treat them before the onset of a new attack.


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Study Rationale

HAE is an autosomal dominant inherited disease that is often under- or misdiagnosed and is predominantly caused by SERPING1 mutations. The disease is usually not diagnosed until late adolescence, and undiagnosed individuals are faced with frequent swelling and gastrointestinal episodes that impair the quality of life. The development of a HAE specific biomarker has several advantages for the patients:

  • The HAE biomarker can facilitate early diagnosis of HAE.
  • The HAE biomarker may serve as a mirror of disease status. It can be used to monitor disease progression and predict impending HAE attacks.
  • Since a biomarker correlates with disease status, it is suitable for validating the efficacy of new treatments.

Information about the Study

Design: Epidemiological, multicenter, and observational study in Germany

Study population: Hereditary Angioedema - type 1/2 patients

Number of Patients: 100

Study duration: 30 months

Objectives:

Primary:

  • Explore the cleaved high-molecular weight kininogen (cHMWK) and other metabolites as a biomarker
  • Study differences between HAE type 1/2 patients without lanadelumab treatment versus patients on lanadelumab treatment

Secondary:

  • To compare cHMWK and other metabolite levels within the edema attack of HAE type 1/2 patients

Tertiary:

  • To validate clinical effects of lanadelumab via monitoring identified metabolite dynamics

ClinicalTrials.gov

Study Design

The patients fulfilling the inclusion criteria will be invited to take part in the study. A blood sample will be taken on seven subsequent visits with 3-month intervals in the first 12 months and 6-month intervals thereafter.

Additionally, every patient will be asked to pay attention to occurring HAE attacks and take a blood sample at the beginning, 3 hours, 6 hours, 12 hours, and 24 hours after the beginning of the attack using a safety lancet, as easily shown in the video below. The samples will be applied to a CentoCard®, which will be sent to CENTOGENE and analyzed in CENTOGENE’s laboratory.

Inclusion Criteria
Informed consent is provided
Patient with Hereditary Angioedema (HAE) type 1/2
Patient has experienced ≥4 HAE attacks within last 12 month before enrolment in the study
Participant is older than 18 years old

HAE Disease Facts

  • A rare hereditary disease characterized by bradykinin-mediated angioedema
  • An autosomal dominant disease caused primarily by mutations in SERPING1, coding for the complement plasma C1 inhibitor protein
  • Published prevalence varies from 1:10,000 to 1:50,000
  • 85% of HAE patients are type 1
  • Clinical symptoms include swelling of the hands, feet, eyelids, lips, and/or genitals as well as gastrointestinal edemas
  • 93% of HAE individuals suffer from recurrent abdominal pain due to gastrointestinal edemas

Contact

For more information please contact:

Dr. Volha Skrahina, Vice Director Clinical Studies
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: Volha.Skrahina(at)centogene(dot)com

Dr. Toni Förster, Clinical Research Associate
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: toni.foerster(at)centogene(dot)com

Susanne Zielke, Clinical Research Associate
CENTOGENE AG
Am Strande 7
18055 Rostock
Germany
Email: Susanne.Zielke(at)centogene(dot)com