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NCT04091113 Clinical Trial

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
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
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Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT01984788 - Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE Phase 2
Completed NCT04888650 - Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Completed NCT02448264 - First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers Phase 1
Completed NCT05118958 - Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations Phase 1
Active, not recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
Completed NCT02819102 - An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates Phase 1
Completed NCT01679912 - A Call Center During HAE Attacks (SOS HAE) Phase 4
Completed NCT01005888 - C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks Phase 3