Hepatitis BREACH-BNCT04914611
Real World Assessment of People Living With Chronic Hepatitis B in Australia
An observational study of Hepatitis B, run by Kirby Institute at 19 sites in Australia.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- How many people
- 10,000 participants
- Where
- 19 sitesAustralia
- Study dates
- 17 Feb 2022to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 1. Nil
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
Australia19 sites, 18 recruiting
- Recruiting
Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)
Adelaide, South Australia, 5000
Catherine Ferguson, +61 8 7074 2788, Catherine.Ferguson@sa.gov.au
Jeffrey Stewart, 0423 782 415, Jeffrey.Stewart@sa.gov.au
- Recruiting
Albany Health Campus, WACHS Great Southern
Albany, Western Australia, 6330
Lloyd Nash, +61 411 209 183, lloyd.nash@health.wa.gov.au
Lloyd Nash, MBBS FRACP MPH
- Recruiting
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Elen Witness, +61 7 5202 3057, Elen.Witness@health.qld.gov.au
James P O'Beirne, MBBS FRACP
- Recruiting
Broome Regional Hospital, WACHS Kimberley
Broome, Western Australia, 6725
Leonie Davidson, 0417 922 394, leonie.davidson@health.wa.gov.au
Sarah C Straw, MBBS FRACP
- Recruiting
Cairns and Hinterland Hospital Health Service
Cairns, Queensland, 4870
Sharna Radlof, +61 7 4226 7981, Sharna.Radlof@health.qld.gov.au
Joshua P Hanson, MBBS
- Recruiting
Torres and Cape Hospital and Health Service
Cairns, Queensland, 4870
Sharna Radlof, +61 7 4226 7981, Sharna.Radlof@health.qld.gov.au
Joshua S Hanson, MBBS
- Recruiting
Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)
Darwin, Northern Territory, 0810
Paula Binks, +61 8 8946 8659, Paula.Binks@menzies.edu.au
Jane Davies, MBBS
- Recruiting
Top End Medical Centre
Darwin, Northern Territory, 0810
Amanda Carey, +61 8 8995 7900, managercas@topendmedicalcentre.com.au
Marilou Capati, MBBS
- Recruiting
Kalgoorlie Health Campus, WACHS Goldfields
Kalgoorlie-Boulder, Western Australia, 6164
Georgina Trotter, 0408903110, Georgina.Trotter@health.wa.gov.au
Georgina Trotter, MBBS
- Not yet recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Janine Roney, +61 3 9076 2296, J.Roney@alfred.org.au
Joseph S Doyle, MBBS FRACP MSc
- Not yet recruiting
Cohealth
Melbourne, Victoria, 3011
Nicole Allard, 03 9448 5502, Nicole.Allard@vidrl.org.au
Nicole Allard, MBBS MPH PhD
- Recruiting
Utopia Refugee and Asylum Seeker Health
Melbourne, Victoria, 3029
Peita Pittella, +61 3 8001 3049, practice.manager@utopiarefugeehealth.com
Lester Mascarenhas, MBChB
- Recruiting
Royal Melbourne Hospital
Melbourne, Victoria, 3050
Roisin McColl, Roisin.McColl@mh.org.au
Benjamin C Cowie, MBBS
- Not yet recruiting
St Vincent's Hospital
Melbourne, Victoria, 3065
Heeba Doughan, +61 3 9231 3550, gastro.ethics@svha.org.au
Alexander Thompson, MBBS
- Active, not recruiting
Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)
Sydney, New South Wales, 2000
- Recruiting
St Vincent's Hospital
Sydney, New South Wales, 2010
Gregory J Dore, MBBS, PhD, +61 2 9385 0898, gdore@kirby.unsw.edu.au
Rebecca J Hickey, +61 2 8382 3825, Rebecca.Hickey@svha.org.au
- Recruiting
Justice Health and Forensic Mental Health Network
Sydney, New South Wales, 2036
Tracey Brown, 02 9700 3224, tracey.brown1@health.nsw.gov.au
Marianne Martinello, MBBS FRACP PhD
- Recruiting
Blacktown Mount Druitt Hospital
Sydney, New South Wales, 2143
Tasnim Hasan, +61 2 9889 1235, tasnim.hasan@sydney.edu.au
Tasnim Hasan, MBBS
- Recruiting
Westmead Hospital
Sydney, New South Wales, 2145
Kindness Bondezi, +61 2 8890 5627, Kindness.Bondezi@health.nsw.gov.au
Jacob George, MBBS
About this study
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.
- Conditions
- Hepatitis B
- Being tested
- No intervention
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| HBsAg Positive | Patients with chronic hepatitis B infection as defined by HBV surface antigen positive Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterisation of HBV
To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B
Measured: July 2027
Secondary outcomes (8)
Socio-demographics of HBV infected population
To characterise the socio-demographic spectrum of people living with chronic HBV
Measured: July 2027
HBV Disease staging
To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
Measured: July 2027
HBV Care Cascade
To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
Measured: July 2027
HBV Treatment and Care
To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
Measured: July 2027
HBV Care and treatment adherence
To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
Measured: July 2027
HCC Surveillance
To assess the rate of surveillance for hepatocellular carcinoma
Measured: July 2027
HBV Disease Progression
To assess the rate of progression from each phase to the subsequent phase of hepatitis B
Measured: July 2027
Liver fibrosis progression
To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma
Measured: July 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start17 Feb 2022
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Gail Matthews, PhD MBBS, Principal investigator, Kirby Insitute, UNSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914611
- Sponsor's protocol ID
- VHCRP2008
- Acronym
- REACH-B
- Status last verified
- May 2026
- First submitted
- 30 May 2021
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Assessment of People Living With Chronic Hepatitis B in Australia
- ClinicalTrials.gov ID
- NCT04914611
- Acronym / sponsor ID
- REACH-B / VHCRP2008
- Conditions
- Hepatitis B
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBsAg Positive | – | Other: No interventionPatients with chronic hepatitis B infection as defined by HBV surface antigen positive |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (1 listed)
- 1. Nil
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | HBsAg Positive |
Primary outcome
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hepatitis B
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Evaluation of Patients With Liver Disease
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Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
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Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gail Matthews, PhD MBBS principal investigator
Kirby Insitute, UNSW
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, run by Kirby Institute at 19 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Carter (+61290654212, jcarter@kirby.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterisation of HBV (time frame: July 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.