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

Hepatitis B Clinical Trial

— REACH-B  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04914611
• Other study ID #: VHCRP2008
• Status: Recruiting
• Start date: February 17, 2022
• Est. completion date: July 1, 2027

Study information

• Verified date: December 2023
• Source: Kirby Institute
• Contact: Jessica Carter
• Phone: +61290654212
• Email: jcarter[@]kirby.unsw.edu.au
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Australia	Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)	Adelaide	South Australia
Australia	Albany Health Campus, WACHS Great Southern	Albany	Western Australia
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Broome Regional Hospital, WACHS Kimberley	Broome	Western Australia
Australia	Cairns and Hinterland Hospital Health Service	Cairns	Queensland
Australia	Torres and Cape Hospital and Health Service	Cairns	Queensland
Australia	Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)	Darwin	Northern Territory
Australia	Top End Medical Centre	Darwin	Northern Territory
Australia	Kalgoorlie Health Campus, WACHS Goldfields	Kalgoorlie	Western Australia
Australia	Cohealth	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Melbourne	Victoria
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Utopia Refugee and Asylum Seeker Health	Melbourne	Victoria
Australia	Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)	Sydney	New South Wales
Australia	Blacktown Mount Druitt Hospital	Sydney	New South Wales
Australia	Justice Health and Forensic Mental Health Network	Sydney	New South Wales
Australia	St Vincent's Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Country where clinical trial is conducted

Australia, 

Outcome

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