Real World Assessment of People Living With Chronic Hepatitis B in Australia
ConditionHepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKirby Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
10,000 Participants
are divided into 1 treatment groupGroup A: HBsAg Positive1 intervention
Trial outcomes
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 2027Secondary outcomes
1
Socio-demographics of HBV infected population
To characterise the socio-demographic spectrum of people living with chronic HBV
Time frame
July 20272
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 20273
HBV Care Cascade
To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
Time frame
July 20274
HBV Treatment and Care
To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
Time frame
July 2027Sponsors and contacts
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Source ClinicalTrials.gov