ClinicalTrials.gg
RecruitingNCT04914611REACH-BUpdated May 19, 2026

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

An observational study in Hepatitis B, sponsored by Kirby Institute. Recruiting at 19 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.

Sponsored by Kirby Institute · Observational

From the registry’s dates

  • Started Feb 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Hepatitis B

Browse trials for

03

In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 365 across 251 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults diagnosed with chronic HBV as defined by a positive HBsAg result at participating sites will be enrolled in the cohort. Participants can be newly diagnosed or existing patients of the service. Data on HBV disease status, liver disease status, HBV monitoring and treatment will be collected six monthly from enrolment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All individuals diagnosed with chronic in the participating study sites are eligible to be included (both newly diagnosed cases and those diagnosed in the past).
  2. 16 years of age or older.
  3. 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

Exclusion Criteria:

1. Nil

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • HBsAg Positive

    Patients with chronic hepatitis B infection as defined by HBV surface antigen positive

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

  1. Characterisation of HBV

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

    Time frame: July 2027

Secondary outcomes

  1. Socio-demographics of HBV infected population

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

    Time frame: July 2027

  2. HBV Disease staging

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

    Time frame: July 2027

  3. HBV Care Cascade

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

    Time frame: July 2027

  4. HBV Treatment and Care

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

    Time frame: July 2027

  5. HBV Care and treatment adherence

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

    Time frame: July 2027

  6. HCC Surveillance

    To assess the rate of surveillance for hepatocellular carcinoma

    Time frame: July 2027

  7. HBV Disease Progression

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

    Time frame: July 2027

  8. Liver fibrosis progression

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

    Time frame: July 2027

07

Study locations

15 of 19 sites recruiting
  • Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)
    Sydney, New South Wales 2000, Australia
    Active, not recruiting

    Not enrolling at this site.

  • St Vincent's Hospital
    Sydney, New South Wales 2010, Australia
    Recruiting
  • Justice Health and Forensic Mental Health Network
    Sydney, New South Wales 2036, Australia
    Recruiting
  • Blacktown Mount Druitt Hospital
    Sydney, New South Wales 2143, Australia
    Recruiting
    • Tasnim Hasan · Contacttasnim.hasan@sydney.edu.au · +61 2 9889 1235
    • Tasnim Hasan, MBBS · Principal investigator
    • Golo Ahlenstiel, MBBS · Sub investigator
    • Ian Wong, MBBS · Principal investigator
  • Westmead Hospital
    Sydney, New South Wales 2145, Australia
    Recruiting
  • Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)
    Darwin, Northern Territory 0810, Australia
    Recruiting
    • Paula Binks · ContactPaula.Binks@menzies.edu.au · +61 8 8946 8659
    • Jane Davies, MBBS · Principal investigator
    • Robert Batey, MBBS · Sub investigator
  • Top End Medical Centre
    Darwin, Northern Territory 0810, Australia
    Recruiting
  • Sunshine Coast University Hospital
    Birtinya, Queensland 4575, Australia
    Recruiting
  • Cairns and Hinterland Hospital Health Service
    Cairns, Queensland 4870, Australia
    Recruiting
  • Torres and Cape Hospital and Health Service
    Cairns, Queensland 4870, Australia
    Recruiting
  • Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)
    Adelaide, South Australia 5000, Australia
    Recruiting
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
    Not yet recruiting
    • Janine Roney · ContactJ.Roney@alfred.org.au · +61 3 9076 2296
    • Joseph S Doyle, MBBS FRACP MSc · Principal investigator
  • Cohealth
    Melbourne, Victoria 3011, Australia
    Not yet recruiting
  • Utopia Refugee and Asylum Seeker Health
    Melbourne, Victoria 3029, Australia
    Recruiting
  • Royal Melbourne Hospital
    Melbourne, Victoria 3050, Australia
    Recruiting
  • St Vincent's Hospital
    Melbourne, Victoria 3065, Australia
    Not yet recruiting
  • Albany Health Campus, WACHS Great Southern
    Albany, Western Australia 6330, Australia
    Recruiting
  • Broome Regional Hospital, WACHS Kimberley
    Broome, Western Australia 6725, Australia
    Recruiting
  • Kalgoorlie Health Campus, WACHS Goldfields
    Kalgoorlie-Boulder, Western Australia 6164, Australia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Jul 2030, 101 months after the start.

Of 69 non-industry observational studies under Hepatitis B, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 126. This study's planned 101 months is above that.

Counting every sponsor, half of 81 studies reached it within 55 months; a quarter within 17 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
May 30, 2021
First posted
Jun 4, 2021
StartActual
Feb 17, 2022
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2030
Last update
May 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04914611
Lead sponsor
Kirby Institute
Responsible party
Sponsor
First posted
Jun 4, 2021
Start date
Feb 17, 2022
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
May 19, 2026

Study contacts

Jessica Carter
Contact
jcarter@kirby.unsw.edu.au
+61290654212
Amanda Erratt
Contact
aerratt@kirby.unsw.edu.au
+61293850882
Gail Matthews, PhD MBBS
principal investigator · Kirby Insitute, UNSW

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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