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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04914611
Acronym
REACH-B
Enrollment
10000
Registered
2021-06-04
Start date
2022-02-17
Completion date
2030-07-31
Last updated
2026-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Brief 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.

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

OTHERNo intervention

No intervention

Sponsors

Kirby Institute
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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). 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

1\. Nil

Design outcomes

Primary

MeasureTime frameDescription
Characterisation of HBVJuly 2027To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B

Secondary

MeasureTime frameDescription
Socio-demographics of HBV infected populationJuly 2027To characterise the socio-demographic spectrum of people living with chronic HBV
HBV Disease stagingJuly 2027To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
HBV Care CascadeJuly 2027To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
HBV Treatment and CareJuly 2027To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
HBV Care and treatment adherenceJuly 2027To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
HCC SurveillanceJuly 2027To assess the rate of surveillance for hepatocellular carcinoma
HBV Disease ProgressionJuly 2027To assess the rate of progression from each phase to the subsequent phase of hepatitis B
Liver fibrosis progressionJuly 2027To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma

Countries

Australia

Contacts

CONTACTJessica Carter
jcarter@kirby.unsw.edu.au+61290654212
CONTACTAmanda Erratt
aerratt@kirby.unsw.edu.au+61293850882
PRINCIPAL_INVESTIGATORGail Matthews, PhD MBBS

Kirby Insitute, UNSW

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 20, 2026