NCT03029728

Brief Summary

International, multicenter, observational, longitudinal monitoring study to identify, validate and/or monitor Mass Spectrometry (MS)-based biomarker/s for Hereditary Angioedeme (HAE) disease and to test the clinical robustness, specificity, and predictive value of theese biomarker/s

Trial Health

93
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
7 countries

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

August 20, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2022

Completed
Last Updated

March 24, 2022

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

January 18, 2017

Last Update Submit

March 23, 2022

Conditions

C1 Esterase Inhibitor DeficiencyAngio EdemaC4 DeficiencyHAEHereditary AngioedemaHereditary Angioedema Type IIHereditary Angioedema Type IIIHereditary Angioedema Type I

Keywords

Hereditary AngioedemaBiomarkerHereditary Angioedema Type IHereditary Angioedema Type IIHereditary Angioedema Type III

Outcome Measures

Primary Outcomes (1)

  • Identification, validation and/or monitoring of mass spectrometry (MS)-based biomarkers of Hereditary Angioedema (HAE) patients

    All samples will be analyzed for the identification of biomarker/s via Liquid Chromatography Multiple Reaction-monitoring Mass Spectrometry (LC/MRM-MS) and compared to merged control, in order to establish the disease-specific biomarker/s. The LC/MRM-MS is performed on an ABSciex 6500 triple quadrupole mass spectrometer, coupled with a Waters Acquity UPLC.

    36 months

Secondary Outcomes (1)

  • Determination of the clinical robustness, specificity, and predictive value of the biomarker(s)

    36 months

Study Arms (1)

Participants with Hereditary Angioedema

Participants diagnosed with Hereditary Angioedema disease aged between 2 months and 60 years

Eligibility Criteria

Age2 Months - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Participants diagnosed with Hereditary Angioedema (HAE) disease

You may qualify if:

  • Informed consent is obtained from the participant or participant's parent/legal guardian
  • The participant is aged between 2 months and 60 years
  • The diagnosis of Hereditary Angioedema is confirmed by CENTOGENE

You may not qualify if:

  • Inability to provide informed consent
  • Participant is younger than 2 months or older than 60 years
  • The diagnosis of Hereditary Angioedema disease is not confirmed by CENTOGENE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arabkir JMC-ICAH

Yerevan, 0014, Armenia

Location

Center of Allergy and Immunology

Tbilisi, 0159, Georgia

Location

Department of Pediatric Genetics, Amrita Institute of Medical Sciences & Research Centre

Kerola, 682041, India

Location

Clinica San Pablo de Surco

Lima, 1030, Peru

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31-501, Poland

Location

Centrul Clinic Mediquest

Târgu Mureş, 547530, Romania

Location

Sakarya University Research and Training Hospital

Sakarya, 54100, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Angioedemas, HereditaryAngioedemaHereditary Angioedema Types I and IIHereditary Angioedema Type III

Condition Hierarchy (Ancestors)

Vascular 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

January 18, 2017

First Posted

January 24, 2017

Study Start

August 20, 2018

Primary Completion

March 11, 2022

Study Completion

March 11, 2022

Last Updated

March 24, 2022

Record last verified: 2021-03

Locations

AR(1)RO(1)PE(1)TU(1)GE(1)PL(1)IN(1)