Menu
Recruiting NCT04914611

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

Observational Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Hepatitis B. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Characterisation of HBV [Time frame: July 2027]
Secondary outcome measures (8)
  • Socio-demographics of HBV infected population [Time frame: July 2027]
  • HBV Disease staging [Time frame: July 2027]
  • HBV Care Cascade [Time frame: July 2027]
  • HBV Treatment and Care [Time frame: July 2027]
  • HBV Care and treatment adherence [Time frame: July 2027]
  • HCC Surveillance [Time frame: July 2027]
  • HBV Disease Progression [Time frame: July 2027]
  • Liver fibrosis progression [Time frame: July 2027]

Eligibility criteria

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

1\. Nil

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 19 centers
  • Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) — Sydney
  • St Vincent's Hospital — Sydney
  • Justice Health and Forensic Mental Health Network — Sydney
  • Blacktown Mount Druitt Hospital — Sydney
  • Westmead Hospital — Sydney
  • Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals) — Darwin
  • Top End Medical Centre — Darwin
  • Sunshine Coast University Hospital — Birtinya
  • … and 11 more centers

Identifiers

NCT: NCT04914611 · VHCRP2008

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗