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NCT Number: NCT04914611

Real World Assessment of People Living With Chronic Hepatitis B in Australia

The REACH-B study establishes an observational cohort study of people living with chronic hepatitis B from a national network, including a diverse range of services, to characterise and monitor hepatitis B linkage to care and treatment requirements amongst this population.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM), Sydney, New South Wales, Australia

Loading trial locations.

About this study

Participants presenting to participating clinics for HBV care within the previous 12 months will be identified and enrolment data will be collected including demographics, laboratory parameters, liver disease assessment, treatment history and clinical management. Follow-up data on HBV treatment and clinical management, liver disease stage and laboratory parameters will be collected at each subsequent visit or at minimum every 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All individuals diagnosed with chronic hepatitis B in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past).
  • 16 years of age or older.
  • Attended the health service for HBV care within the prior 12 months from study commencement (retrospective recruitment) OR Attending the health service for HBV care from study commencement (prospective recruitment)

Exclusion criteria

  • Nil

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Characterisation of HBV

    Time frame: July 2027

    To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B

Secondary outcomes

  1. Socio-demographics of HBV infected population

    Time frame: July 2027

    To characterise the socio-demographic spectrum of people living with chronic HBV

  2. HBV Disease staging

    Time frame: July 2027

    To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection

  3. HBV Care Cascade

    Time frame: July 2027

    To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level

  4. HBV Treatment and Care

    Time frame: July 2027

    To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment

  5. HBV Care and treatment adherence

    Time frame: July 2027

    To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation

  6. HCC Surveillance

    Time frame: July 2027

    To assess the rate of surveillance for hepatocellular carcinoma

  7. HBV Disease Progression

    Time frame: July 2027

    To assess the rate of progression from each phase to the subsequent phase of hepatitis B

  8. Liver fibrosis progression

    Time frame: July 2027

    To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Erratt

CONTACT

[email protected]

+61293850882

Jessica Carter

CONTACT

[email protected]

+61290654212

Sponsors and collaborators

Lead sponsor

Kirby Institute

Other Gov

Registry information

Acronym: REACH-B

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Jun 4, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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