Trial Review

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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.
Scientific title
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Secondary ID [1] 287484 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
NAC (STOP) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 296228 0
Condition category
Condition code
Infection 296499 296499 0 0
Other infectious diseases
Oral and Gastrointestinal 296552 296552 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 292871 0
Treatment: Other
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296127 0
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.
Timepoint [1] 296127 0
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.
Secondary outcome [1] 317561 0
To identify novel immunological determinants of SVR, the assessment will be by serum assay.
Timepoint [1] 317561 0
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.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/07/2014
Actual
28/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292062 0
Government body
Name [1] 292062 0
National Health and Medical Research Council grant
Country [1] 292062 0
Australia
Primary sponsor type
Individual
Name
Professor Alexander Thompson
Address
Department of Gastroenterology
Level 4, Daly Wing
St Vincent's Hospital
35 Victoria Parade
Fitzroy,
Victoria, Australia, 3065
Country
Australia
Secondary sponsor category [1] 290737 0
None
Name [1] 290737 0
Address [1] 290737 0
Country [1] 290737 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293546 0
ST Vincent's Hospital Melbourne
Ethics committee address [1] 293546 0
35 Victoria Parade
Fitzroy,
Victoria, 3065
Ethics committee country [1] 293546 0
Australia
Date submitted for ethics approval [1] 293546 0
Approval date [1] 293546 0
29/05/2014
Ethics approval number [1] 293546 0

Summary
Brief summary
To evaluate the rate of sustained virological response among HBeAg-negative chronic hepatitis B patients who discontinue long-term NA therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60394 0
Prof Alexander Thompson
Address 60394 0
St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
Country 60394 0
Australia
Phone 60394 0
+61392313581
Fax 60394 0
Email 60394 0
[email protected]
Contact person for public queries
Name 60395 0
Gareth Burns
Address 60395 0
St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
Country 60395 0
Australia
Phone 60395 0
+61392313518
Fax 60395 0
Email 60395 0
[email protected]
Contact person for scientific queries
Name 60396 0
Gareth Burns
Address 60396 0
St Vincent's Hospital
35 Victoria Parade
Fitzroy
Victoria, 3065
Country 60396 0
Australia
Phone 60396 0
+61392313518
Fax 60396 0
Email 60396 0
[email protected]

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.