Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria
Recruiting · NCT06834178 · Observational (researchers observe without assigning treatment) · Lead sponsor: Vanessa Stadlbauer-Koellner, MD
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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)
Where it is running
1 location listed.
- Department of Internal Medicine, Division of Gastroenterology and Hepatology - Graz, Styra, Austria