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Trial registered on ANZCTR
Registration number
ACTRN12615001063505
Ethics application status
Approved
Date submitted
16/09/2015
Date registered
12/10/2015
Date last updated
18/12/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
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Scientific title
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
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Secondary ID [1]
287484
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Nil
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Universal Trial Number (UTN)
Nil
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Trial acronym
NAC (STOP) Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hepatitis B
296228
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Condition category
Condition code
Infection
296499
296499
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0
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Other infectious diseases
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Oral and Gastrointestinal
296552
296552
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Evaluation of the rate of sustained virological response among HBeAg-negativechronic hepatitis B patients who discontinue long-term NA therapy.
During this study participants will cease their prescribed medications, this will occur with immediate effect once enrolled into the study. The duration of cessation will be indefinite, unless clinically indicated for NA therapy re-start. Participants will be monitored as per protocol following cessation, monitoring will be by clinic visit and through blood test to monitor virological response. Clinical visits will be at the intervals of week 2, week, 4, week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the participant will have completed the trial. Once the participant has completed the trial they will not commence again, the aim is for an indefinite cessation of NA therapy.
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Intervention code [1]
292871
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Treatment: Other
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Comparator / control treatment
Uncontrolled
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The primary aim of this study is to evaluate the rate of sustained virological response among HBeAg-negative chronic hepatitis B patients who discontinue long-term NA therapy. The outcome is to be assessed by serum assay.
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Assessment method [1]
296127
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Timepoint [1]
296127
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Patients will be closely followed for 2 years prospectively, at the following time points; 2 weeks post cessation, 4 weeks, 8 weeks, 12 weeks, 18 weeks, then from 6 months the visits will be 3 monthly out to two years.
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Secondary outcome [1]
317561
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To identify novel immunological determinants of SVR, the assessment will be by serum assay.
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Assessment method [1]
317561
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Timepoint [1]
317561
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Patients will be closely followed for 2 years prospectively, at the following time points; 2 weeks post cessation, 4 weeks, 8 weeks, 12 weeks, 18 weeks, then from 6 months the visits will be 3 monthly out to two years.
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Eligibility
Key inclusion criteria
Male or Female, age >18 years
Subjects must be able to understand and agree to comply with the prescribed intervention (NA cessation), visits and reliably communicate with study personal about adverse events
Able to provide informed consent.
Chronic Hepatitis B virus infection
HBeAg negative at time if initiation of NA therapy
Meet current APASL guidelines for consideration of antiviral cessation:
- uninterrupted NA treatment for >2 years and
- undetectable serum HBV DNA on three separate occasions >= 6 months apart (undetectable defined by a value < lower limit of detection using a sensitive commercial PCR assay)
Normal serum ALT levels (according to the uppers limit of normal of the local laboratory)
Minimal to moderate liver fibrosis defined as:
- METAVIR liver fibrosis stage F0-F3 inclusive prior to initial NA therapy and/or
- Transient liver elastogram (TLE) (Fibroscan) < /= 9.6 kPa at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
HBeAg positive chronic hepatitis B at the time of NA initiation
HBV associated extra hepatic manifestations
Documented or suspected hepatocellular carcinoma (HCC)
History of decompensated liver disease
Compensated cirrhosis defined as:
- METAVIR liver fibrosis stage 4 on pre-treatment biopsy; OR
- TLE > 9.6 kPa at screening
Co-infection with HIV,HCV or HDV
Latrogenic or disease related immunosuppression (e.g. treatment with systemic glucocorticoids, TNFa-antibodies, and other immunosuppressive drugs)
Significant alcohol consumption (> 30 g/day for women and > 50 g/day for men)
Current known history of cancer within 5 years of screening
Pregnant or breast feeding
Other known significant liver disease (including but not limited to haemochromatosis, autoimmune hepatitis, alcoholic liver disease)
Participation in any other interventional trial
Poor Venous access
Suspected lack of compliance
Any medical or social reason which in the opinion of the investigator would make the subject inappropriate for the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
28/07/2014
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Actual
28/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
292062
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Government body
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Name [1]
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National Health and Medical Research Council grant
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Australia
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Country [1]
292062
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Australia
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Primary sponsor type
Individual
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Name
Professor Alexander Thompson
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Address
Department of Gastroenterology
Level 4, Daly Wing
St Vincent's Hospital
35 Victoria Parade
Fitzroy,
Victoria, Australia, 3065
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Country
Australia
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Secondary sponsor category [1]
290737
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None
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Name [1]
290737
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Address [1]
290737
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Country [1]
290737
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
293546
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ST Vincent's Hospital Melbourne
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Ethics committee address [1]
293546
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35 Victoria Parade Fitzroy, Victoria, 3065
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Ethics committee country [1]
293546
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Australia
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Date submitted for ethics approval [1]
293546
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Approval date [1]
293546
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29/05/2014
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Ethics approval number [1]
293546
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Summary
Brief summary
To evaluate the rate of sustained virological response among HBeAg-negative chronic hepatitis B patients who discontinue long-term NA therapy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Alexander Thompson
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Address
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St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
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Country
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Australia
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Phone
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+61392313581
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Gareth Burns
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Address
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St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
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Country
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Australia
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Phone
60395
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+61392313518
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Fax
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Email
60395
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[email protected]
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Contact person for scientific queries
Name
60396
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Gareth Burns
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Address
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St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
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Country
60396
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Australia
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Phone
60396
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+61392313518
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Fax
60396
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Email
60396
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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