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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04914611




Registration number
NCT04914611
Ethics application status
Date submitted
30/05/2021
Date registered
4/06/2021

Titles & IDs
Public title
Real World Assessment of People Living With Chronic Hepatitis B in Australia
Scientific title
Real World Assessment of People Living With Chronic Hepatitis B in Australia
Secondary ID [1] 0 0
VHCRP2008
Universal Trial Number (UTN)
Trial acronym
REACH-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - No intervention

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


Other interventions: No intervention
No intervention
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterisation of HBV
Timepoint [1] 0 0
July 2027
Secondary outcome [1] 0 0
Socio-demographics of HBV infected population
Timepoint [1] 0 0
July 2027
Secondary outcome [2] 0 0
HBV Disease staging
Timepoint [2] 0 0
July 2027
Secondary outcome [3] 0 0
HBV Care Cascade
Timepoint [3] 0 0
July 2027
Secondary outcome [4] 0 0
HBV Treatment and Care
Timepoint [4] 0 0
July 2027
Secondary outcome [5] 0 0
HBV Care and treatment adherence
Timepoint [5] 0 0
July 2027
Secondary outcome [6] 0 0
HCC Surveillance
Timepoint [6] 0 0
July 2027
Secondary outcome [7] 0 0
HBV Disease Progression
Timepoint [7] 0 0
July 2027
Secondary outcome [8] 0 0
Liver fibrosis progression
Timepoint [8] 0 0
July 2027

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nil

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) - Sydney
Recruitment hospital [2] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [3] 0 0
Justice Health and Forensic Mental Health Network - Sydney
Recruitment hospital [4] 0 0
Blacktown Mount Druitt Hospital - Sydney
Recruitment hospital [5] 0 0
Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Menzies School of Health Research (Royal Darwin & Alice Springs Hospitals) - Darwin
Recruitment hospital [7] 0 0
Top End Medical Centre - Darwin
Recruitment hospital [8] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [9] 0 0
Cairns and Hinterland Hospital Health Service - Cairns
Recruitment hospital [10] 0 0
Torres and Cape Hospital and Health Service - Cairns
Recruitment hospital [11] 0 0
Central Adelaide Local Health Network (Royal Adelaide & The Queen Elizabeth Hospitals) - Adelaide
Recruitment hospital [12] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [13] 0 0
Cohealth - Melbourne
Recruitment hospital [14] 0 0
Utopia Refugee and Asylum Seeker Health - Melbourne
Recruitment hospital [15] 0 0
Royal Melbourne Hospital - Melbourne
Recruitment hospital [16] 0 0
St Vincent's Hospital - Melbourne
Recruitment hospital [17] 0 0
Albany Health Campus, WACHS Great Southern - Albany
Recruitment hospital [18] 0 0
Broome Regional Hospital, WACHS Kimberley - Broome
Recruitment hospital [19] 0 0
Kalgoorlie Health Campus, WACHS Goldfields - Kalgoorlie
Recruitment postcode(s) [1] 0 0
2000 - Sydney
Recruitment postcode(s) [2] 0 0
2010 - Sydney
Recruitment postcode(s) [3] 0 0
2036 - Sydney
Recruitment postcode(s) [4] 0 0
2143 - Sydney
Recruitment postcode(s) [5] 0 0
2145 - Sydney
Recruitment postcode(s) [6] 0 0
0810 - Darwin
Recruitment postcode(s) [7] 0 0
4575 - Birtinya
Recruitment postcode(s) [8] 0 0
4870 - Cairns
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
3004 - Melbourne
Recruitment postcode(s) [11] 0 0
3011 - Melbourne
Recruitment postcode(s) [12] 0 0
3029 - Melbourne
Recruitment postcode(s) [13] 0 0
3050 - Melbourne
Recruitment postcode(s) [14] 0 0
3065 - Melbourne
Recruitment postcode(s) [15] 0 0
6330 - Albany
Recruitment postcode(s) [16] 0 0
6725 - Broome
Recruitment postcode(s) [17] 0 0
6164 - Kalgoorlie

Funding & Sponsors
Primary sponsor type
Government body
Name
Kirby Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, PhD MBBS
Address 0 0
Kirby Insitute, UNSW
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jessica Carter
Address 0 0
Country 0 0
Phone 0 0
+61290654212
Fax 0 0
Email 0 0
jcarter@kirby.unsw.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04914611