An observational study in HBV, HCV and HDV, sponsored by Vanessa Stadlbauer-Koellner, MD. Recruiting at 1 site in Austria. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Vanessa Stadlbauer-Koellner, MD · Observational
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.
We hypothesize that in South-East Austria, a relevant number of persons are unaware of their HCV infection or their HDV status in case of HBV coinfection and therefore not yet sufficiently linked to care.
The study consists of two parts:
2.1. HCV cohort Patients in the HCV cohort will be invited to laboratory evaluation. Patient visits correspond to routine and are not specific to the study - they include platelet count, liver biochemistry tests, virologic parameters (HCV, HIV, HBV), liver stiffness measurement using elastography (Fibroscan®, Echosens, France), counselling regarding HCV transmission and persons in whom plasma HCV RNA is detectable will be offered treatment with direct-acting antivirals (DAAs). The choice of DAA will be made according to individual comorbidities, comedications, previous HCV treatments, prescriber and personal preferences. Routine surveillance data under DAA treatment will be recorded. SVR is defined as HCV RNA not detectable after the end of DAA treatment. Furthermore, the suspected route of HCV transmission will be documented.
2.2. HBV cohort In the HBV cohort, patients with missing or positive but untreated HDV serology and with positive HBV viral load and negative HDV serology, but no evidence of linkage to care will be contacted via telephone or mail and invited for evaluation as described above and linked to care including treatment of HBV infection according to the applicable clinical practice guidelines as well as prescriber and personal preferences.
In case of positive HDV serology, HDV RNA testing will be performed and depending on the result, treatment of HBV/HDV coinfection will be initiated according to the applicable clinical practice guidelines as well as prescriber and personal preferences. Furthermore, the suspected route of HBV/HDV transmission will be assessed. Patient visit is part of routine treatment and done according to the respective treatment guidelines and the requirements of health insurance policy.
The active study participation ends with the linkage-to-care. The treatment of the viral hepatitis infection is not part of the study any more. The outcome of therapy will be assessed via chart review in retrospect.
92 studies on the registry are indexed under Coinfection; 12 are open to participants now.
This study's planned enrollment of 100 is below the median of 347 across 38 observational studies indexed under Coinfection.
Browse Coinfection studies →Vanessa Stadlbauer-Koellner, MD is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female patients in South-East Austria with undiagnosed HCV infection or with unknown HDV status in case of HBV infection.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the HCV cohort will be invited to laboratory evaluation. Patient visits correspond to routine and are not specific to the study - they include platelet count, liver biochemistry tests, virologic parameters (HCV, HIV, HBV), liver stiffness measurement using elastography (Fibroscan®, Echosens, France), counselling regarding HCV transmission and persons in whom plasma HCV RNA is detectable will be offered treatment with direct-acting antivirals (DAAs). The choice of DAA will be made according to individual comorbidities, comedications, previous HCV treatments, prescriber and personal preferences. Routine surveillance data under DAA treatment will be recorded. SVR is defined as HCV RNA not detectable after the end of DAA treatment. Furthermore, the suspected route of HCV transmission will be documented.
In the HBV cohort, patients with missing or positive but untreated HDV serology and with positive HBV viral load and negative HDV serology, but no evidence of linkage to care will be contacted via telephone or mail and invited for evaluation as described above and linked to care including treatment of HBV infection according to the applicable clinical practice guidelines as well as prescriber and personal preferences. In case of positive HDV serology, HDV RNA testing will be performed and depending on the result, treatment of HBV/HDV coinfection will be initiated according to the applicable clinical practice guidelines as well as prescriber and personal preferences. Furthermore, the suspected route of HBV/HDV transmission will be assessed. Patient visit is part of routine treatment and done according to the respective treatment guidelines and the requirements of health insurance policy.
Number of HCV patients that can be linked to care
To identify patients with detectable plasma HCV-RNA and subsequently treat them (HCV cohort)
Time frame: 10/2024 - 10/2026
Number of HDV patients that can be linked to care
To identify patients with HDV infection and link them to care (HBV/HDV cohort)
Time frame: 10/2024 - 10/2026
Virological response (SVR) rate
To assess the sustained virological response (SVR) rate in this macroelimination program
Time frame: 10/2024 - 10/2026
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
Time frame: 10/2024 - 10/2026
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
Time frame: 10/2024 - 10/2026
Number of HCV re-infections
To estimate the number of HCV re-infections
Time frame: 10/2024 - 10/2026
Number of patients with HBV infection who were not tested for HDV infection
To estimate the diagnostic gap in patients with HBV infection who were not tested for HDV infection
Time frame: 10/2024 - 10/2026
Number of patients with HBV infection who were not tested for HDV infection
Time frame: 10/2024 - 10/2026
Number of HBV patients with HDV infection
Time frame: 10/2024 - 10/2026
Plan to share: Undecided
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Vanessa Stadlbauer-Koellner, MD