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

NCT ID: NCT04914611

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-17

Study Completion Date

2027-07-01

Brief Summary

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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

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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

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HBsAg Positive

Patients with chronic hepatitis B infection as defined by HBV surface antigen positive

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gail Matthews, PhD MBBS

Role: PRINCIPAL_INVESTIGATOR

Kirby Insitute, UNSW

Locations

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Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM)

Sydney, New South Wales, Australia

Site Status ACTIVE_NOT_RECRUITING

St Vincent's Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Justice Health and Forensic Mental Health Network

Sydney, New South Wales, Australia

Site Status RECRUITING

Blacktown Mount Druitt Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Westmead Hospital

Sydney, New South Wales, Australia

Site Status RECRUITING

Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals)

Darwin, Northern Territory, Australia

Site Status RECRUITING

Top End Medical Centre

Darwin, Northern Territory, Australia

Site Status RECRUITING

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Site Status RECRUITING

Cairns and Hinterland Hospital Health Service

Cairns, Queensland, Australia

Site Status RECRUITING

Torres and Cape Hospital and Health Service

Cairns, Queensland, Australia

Site Status RECRUITING

Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals)

Adelaide, South Australia, Australia

Site Status RECRUITING

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Cohealth

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Utopia Refugee and Asylum Seeker Health

Melbourne, Victoria, Australia

Site Status RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

St Vincent's Hospital

Melbourne, Victoria, Australia

Site Status NOT_YET_RECRUITING

Albany Health Campus, WACHS Great Southern

Albany, Western Australia, Australia

Site Status RECRUITING

Broome Regional Hospital, WACHS Kimberley

Broome, Western Australia, Australia

Site Status RECRUITING

Kalgoorlie Health Campus, WACHS Goldfields

Kalgoorlie-Boulder, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Jessica Carter

Role: CONTACT

Phone: +61290654212

Email: [email protected]

Amanda Erratt

Role: CONTACT

Phone: +61293850882

Email: [email protected]

Facility Contacts

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Gregory J Dore, MBBS, PhD

Role: primary

Rebecca J Hickey

Role: backup

Tracey Brown

Role: primary

Tasnim Hasan

Role: primary

Kindness Bondezi

Role: primary

Paula Binks

Role: primary

Amanda Carey

Role: primary

Elen Witness

Role: primary

Sharna Radlof

Role: primary

Sharna Radlof

Role: primary

Catherine Ferguson

Role: primary

Jeffrey Stewart

Role: backup

Janine Roney

Role: primary

Nicole Allard

Role: primary

Peita Pittella

Role: primary

Roisin McColl

Role: primary

Heeba Doughan

Role: primary

Lloyd Nash

Role: primary

Leonie Davidson

Role: primary

Georgina Trotter

Role: primary

Other Identifiers

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VHCRP2008

Identifier Type: -

Identifier Source: org_study_id