Hereditary Angioedema Kininogen Assay

Hereditary Angioedema Clinical Trial

— HAEKA  

Official title:

Hereditary Angioedema Kininogen Assay: A Multicenter, Epidemiological, Observational Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04091113
• Other study ID #: HAEKA 01-2019
• Status: Terminated
• Start date: September 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: CENTOGENE GmbH Rostock
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: December 31, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	Klinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Düsseldorf,	Düsseldorf
Germany	Klinikum der Johann-Wolfgang-Goethe-Universität	Frankfurt
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitäts-Hautklinik Leipzig	Leipzig
Germany	Hämophilie-Zentrum Rhein Main GmbH	Mörfelden-Walldorf
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
CENTOGENE GmbH Rostock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	All samples will be analyzed for potential biomarker candidates via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS).	30 months
Primary	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.	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).	30 months
Secondary	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.	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).	30 months