Non-interventional Study to Assess the Number of People With Untreated/Unknown HBV + HDV and HCV in South-East Austria

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorVanessa Stadlbauer-Koellner, MD

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: HCV Cohort
Group B: HBV Cohort

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

Virological response (SVR) rate

To assess the sustained virological response (SVR) rate in this macroelimination program

Time frame
10/2024 - 10/2026
2

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
3

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
4

Number of HCV re-infections

To estimate the number of HCV re-infections

Time frame
10/2024 - 10/2026

Other outcomes

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