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

Recruiting

• Conditions: Hepatitis B
• Interventions: Other: No intervention

• Registration Number: NCT04914611
• Lead Sponsor: Kirby Institute

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.

Study Timeline

• Study First Submitted: 2021-05-30
• Study First Submitted QC: 2021-05-30
• Study First Posted: 2021-06-04
• Study Start: 2022-02-17
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2026-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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)

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Exclusion Criteria

1. Nil

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HBsAg Positive	No intervention	Patients with chronic hepatitis B infection as defined by HBV surface antigen positive

Primary Outcome Measures

Name	Time	Method
Characterisation of HBV	July 2027	To characterise and monitor hepatitis B linkage to care and treatment requirements amongst people living with chronic hepatitis B

Secondary Outcome Measures

Name	Time	Method
HCC Surveillance	July 2027	To assess the rate of surveillance for hepatocellular carcinoma
HBV Treatment and Care	July 2027	To monitor the uptake of recommended hepatitis B clinical care, including antiviral treatment
Socio-demographics of HBV infected population	July 2027	To characterise the socio-demographic spectrum of people living with chronic HBV
HBV Care and treatment adherence	July 2027	To monitor the adherence to recommended hepatitis B care, including the patterns of antiviral use and cessation
HBV Disease staging	July 2027	To assess the proportion of individuals in each phase of the disease, based on the natural history of hepatitis B infection
HBV Disease Progression	July 2027	To assess the rate of progression from each phase to the subsequent phase of hepatitis B
HBV Care Cascade	July 2027	To assess the proportion of individuals who are eligible for each recommended hepatitis B clinical care level
Liver fibrosis progression	July 2027	To assess the rate of liver fibrosis progression, including the development of cirrhosis, decompensated cirrhosis, and hepatocellular carcinoma

Trial Locations

Locations (18)

Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM); 🇦🇺 Sydney, New South Wales, Australia

St Vincent's Hospital; 🇦🇺 Melbourne, Victoria, Australia

Justice Health and Forensic Mental Health Network; 🇦🇺 Sydney, New South Wales, Australia

Blacktown Mount Druitt Hospital; 🇦🇺 Sydney, New South Wales, Australia

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia

Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals); 🇦🇺 Darwin, Northern Territory, Australia

Top End Medical Centre; 🇦🇺 Darwin, Northern Territory, Australia

Sunshine Coast University Hospital; 🇦🇺 Birtinya, Queensland, Australia

Cairns and Hinterland Hospital Health Service; 🇦🇺 Cairns, Queensland, Australia

Torres and Cape Hospital and Health Service; 🇦🇺 Cairns, Queensland, Australia

Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals); 🇦🇺 Adelaide, South Australia, Australia

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Cohealth; 🇦🇺 Melbourne, Victoria, Australia

Utopia Refugee and Asylum Seeker Health; 🇦🇺 Melbourne, Victoria, Australia

Royal Melbourne Hospital; 🇦🇺 Melbourne, Victoria, Australia

Albany Health Campus, WACHS Great Southern; 🇦🇺 Albany, Western Australia, Australia

Broome Regional Hospital, WACHS Kimberley; 🇦🇺 Broome, Western Australia, Australia

Kalgoorlie Health Campus, WACHS Goldfields; 🇦🇺 Kalgoorlie, Western Australia, Australia