NCT04091113

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 10, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

September 6, 2019

Last Update Submit

March 9, 2022

Conditions

Hereditary Angioedema

Keywords

Hereditary AngioedemaCleaved high-molecular weight kininogenHereditary Angioedema Type IHereditary Angioedema Type II

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (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.

    30 months

Other Outcomes (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.

    30 months

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hereditary Angioedema type 1/2 patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Charité - Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

Klinik für Hals-Nasen-Ohrenheilkunde, Universitätsklinikum Düsseldorf,

Düsseldorf, 40225, Germany

Location

Klinikum der Johann-Wolfgang-Goethe-Universität

Frankfurt, 60596, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitäts-Hautklinik Leipzig

Leipzig, 04103, Germany

Location

Hämophilie-Zentrum Rhein Main GmbH

Mörfelden-Walldorf, 64546, Germany

Location

Universitätsklinikum Ulm

Ulm, 89075, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

MeSH Terms

Conditions

Angioedemas, HereditaryHereditary Angioedema Types I and II

Condition Hierarchy (Ancestors)

AngioedemaVascular DiseasesCardiovascular DiseasesHereditary Complement Deficiency DiseasesPrimary Immunodeficiency DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesUrticariaSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesImmunologic Deficiency Syndromes

Study Officials

  • Peter Bauer, MD

    Centogene GmbH

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 16, 2019

Study Start

September 1, 2019

Primary Completion

September 12, 2021

Study Completion

December 31, 2021

Last Updated

March 10, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)