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

Sponsor
Vanessa Stadlbauer-Koellner, MD
Study ID
NCT06834178
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 30, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Number of HCV patients that can be linked to care [ Time Frame: 10/2024 - 10/2026 ]

Central Contacts

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