The main goal of the Hepacor study is to define the relationship between risk groups and hepatitis C virus (HCV) carriers in the Czech Republic.
Subjects involved in the study:
MEDIREX GROUP ACADEMY n.o. as the “implementer of the research project” and 15 – 20 centres – health care providers in general medicine and internal medicine in the Czech Republic as the “investigator”.
700 patients, who met the admission and exclusion criteria, were gradually enrolled in the study.
The medical history of these patients focuses on risk factors of HCV infection. Blood samples taken from the patients are used for the detection of hepatitis C virus (HCV) antibodies.
The project uses anti–HCV chemiluminescent microparticle immunoassay (CMIA) methodology for the detection of antibodies as the primary method of detecting hepatitis C virus carriers. Positive findings are subsequently confirmed by HCV RNA using the PCR method (Polymerase chain reaction).
Anamnesis and screening results are recorded in the eCRF system and subsequently reviewed.
No medicine has been tested by the study. This study is purely observational and the schedule of visits at the physician’s office as well as all treatment regimens have been determined by the attending physician in compliance with common clinical practice.
The study involved patients meeting the admission and exclusion criteria. The predefined criteria were met and the study involved a sample of as many as 700 patients. HCV antibody detection serum was taken from the patients. The conclusions of serological diagnostics are followed by findings, which are subsequently recorded in the online e-CRF system.
Patient recruitment: from 1st November, 2015 to 30th May, 2016
Data collection completed by: 30th June, 2016
Statistical processing and assessment of the data collected: 1st January, 2017 to 1st January, 2017
Publication of results: from 1st January, 2017 – 31st December, 2017
doc. MUDr. Petr Husa, CSc.
- Clinic of Infectious Diseases, Faculty of Medicine, Masaryk University and Teaching Hospital in Brno
- Jihlavská 20
- 625 00 Brno, Czech Republic
- +420 532 232 201