About this trial
The HEAL-S study is a non-interventional study with retrospective data analysis. It consists of two parts. First a retrospective analysis based on nucleic acid testing (NAT) results will be performed. Two cohorts (HCV) and (HBV) will be established. Patients falling into one (or both) of the two cohorts will be invited to a prospective linkage-to-care study. In this part, patients are invited to the clinic, where the possibility of hepatitis treatment will be discussed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The target population for the HCV cohort consists of individuals with detectable plasma HCV RNA at the latest observation.
The target population for the HBV cohort consists of individuals with detectable plasma HBV RNA at any time and no recorded HDV testing or a positive HDV serology.
Disqualifiers
No valid SVRN (german: Sozialversicherungsnummer, english: Social insurance number)
No contact details available
Documented Sustained Virological Response (HCV cohort)
Documented assessment of HDV status (HBV cohort)
Trial population
Male and female patients in South-East Austria with undiagnosed HCV infection or with unknown HDV status in case of HBV infection.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Number of HCV patients that can be linked to care
To identify patients with detectable plasma HCV-RNA and subsequently treat them (HCV cohort)
Number of HDV patients that can be linked to care
To identify patients with HDV infection and link them to care (HBV/HDV cohort)
Secondary outcomes
Virological response (SVR) rate
To assess the sustained virological response (SVR) rate in this macroelimination program
Prevalence of HCV, HBV and HDV infection in South-East Austria
To estimate the prevalence of HCV, HBV and HDV infection in South-East Austria
Number of South-East Austria HCV patients treated since DAA treatment has been available
To estimate the number of South-East Austrian HCV patients treated since DAA treatment has been available
Number of HCV re-infections
To estimate the number of HCV re-infections
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vanessa Stadlbauer-Koellner, MD
Lead sponsor
Medical University of Graz
Sponsor institution
Medical University of Graz
Collaborator