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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02581033
Registration number
NCT02581033
Ethics application status
Date submitted
15/10/2015
Date registered
20/10/2015
Date last updated
14/10/2016
Titles & IDs
Public title
Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in 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]
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032/14 Protocol # :APP106653
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Universal Trial Number (UTN)
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Trial acronym
STOP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B.
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Condition category
Condition code
Infection
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Other infectious diseases
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Oral and Gastrointestinal
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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
Treatment: Drugs - Nucleoside Analogue therapy
Experimental: Nucleoside analogue therapy cessation - To determine if a sustained virological response can be achieved after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Treatment: Drugs: Nucleoside Analogue therapy
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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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]
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Timepoint [1]
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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, to observe for virological changes.
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Secondary outcome [1]
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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]
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Timepoint [1]
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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?
Yes
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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
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2014
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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
1/05/2018
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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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Recruitment hospital [1]
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St Vincent's Hospital - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
St Vincent's Hospital Melbourne
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/ct2/show/NCT02581033
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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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Alexander Thompson, MD
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Address
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St Vincent's Hospital Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gareth Burns, MD
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Address
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Country
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Phone
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+61309231 3581
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02581033
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