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

NCT06834178 | Not Yet Recruiting

• 1 other identifier: 1173/2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HBV; HCV; HDV; Coinfection; Hepatitis B Coinfection; Hepatitis B

Keywords

HBV; HCV; HDV; Hepatitis B and D coinfection; untreated hepatitis; Hepatitis B; Hepatitis C; Hepatitis treatment

Outcome Measures

Primary Outcomes (2)

• Number of HCV patients that can be linked to care

  To identify patients with detectable plasma HCV-RNA and subsequently treat them (HCV cohort)

  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)

  10/2024 - 10/2026

Secondary Outcomes (7)

• Virological response (SVR) rate

  10/2024 - 10/2026

• Prevalence of HCV, HBV and HDV infection in South-East Austria

  10/2024 - 10/2026

• Number of South-East Austria HCV patients treated since DAA treatment has been available

  10/2024 - 10/2026

• Number of HCV re-infections

  10/2024 - 10/2026

• Number of patients with HBV infection who were not tested for HDV infection

  10/2024 - 10/2026

Study Arms (2)

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.

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients in South-East Austria with undiagnosed HCV infection or with unknown HDV status in case of HBV infection.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Vanessa Stadlbauer-Koellner, MD: lead
• Medical University of Graz: collaborator

Study Sites (1)

Department of Internal Medicine, Division of Gastroenterology and Hepatology

Graz, Styra, 8036, Austria

Location

MeSH Terms

Conditions

Coinfection; Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Vanessa Stadlbauer-Köllner, Univ. Prof. Dr.

  Medical University of Graz, Department of Gastroenterology and Hepatology, Medical University of Graz

  PRINCIPAL INVESTIGATOR

• Harald H. Kessler, Univ. Prof. Dr.

  Diagnostic and Research Institute of Hygiene, Microbiology and Environmental Medicine, Medical University of Graz

  STUDY DIRECTOR

Central Study Contacts

Vanessa Stadlbauer, Univ. Prof. Dr.

CONTACT

0043 316 385; vanessa.stadlbauer@medunigraz.at

Lavra Celcer, MPharm

CONTACT

gestudien@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ. Prof. Dr. Vanessa Stadlbauer-Köllner

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Locations

AU (1)