Hereditary Angioedema Clinical Trial
— BioHAEOfficial title:
Biomarker for Hereditary AngioEdema Disease: An International, Multicenter, Longitudinal Monitoring Protocol
NCT number | NCT03029728 |
Other study ID # | BHAE 06-2018 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 20, 2018 |
Est. completion date | March 11, 2022 |
Verified date | March 2021 |
Source | CENTOGENE GmbH Rostock |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 42 |
Est. completion date | March 11, 2022 |
Est. primary completion date | March 11, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 60 Years |
Eligibility | INCLUSION CRITERIA - 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 EXCLUSION CRITERIA - 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 |
Country | Name | City | State |
---|---|---|---|
Armenia | Arabkir JMC-ICAH | Yerevan | |
Georgia | Center of Allergy and Immunology | Tbilisi | |
India | Department of Pediatric Genetics, Amrita Institute of Medical Sciences & Research Centre | Kerola | |
Peru | Clinica San Pablo de Surco | Lima | |
Poland | Szpital Uniwersytecki w Krakowie | Krakau | |
Romania | Centrul Clinic Mediquest | Târgu-Mures | |
Turkey | Sakarya University Research and Training Hospital | Sakarya |
Lead Sponsor | Collaborator |
---|---|
CENTOGENE GmbH Rostock |
Armenia, Georgia, India, Peru, Poland, Romania, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Determination of the clinical robustness, specificity, and predictive value of the biomarker(s) | Samples will be analyzed for the identified biomarker candidates 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 |
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