- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02581033
Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in Hepatitis B Patients (STOP)
Determinants of Sustained Virological Response After Discontinuation of Long-term Nucleoside Analogue Therapy in Chronic Hepatitis B Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gareth Burns, MD
- Phone Number: +61309231 3581
- Email: gareth.burns@svha.org.au
Study Locations
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Victoria
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Melbourne, Victoria, Australia, 3065
- Recruiting
- St Vincent's hospital
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Contact:
- Gareth Burns, MD
- Phone Number: +61392313581
- Email: gareth.burns@svha.org.au
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Contact:
- John Gough, RN
- Phone Number: +61392313518
- Email: john.gough@svha.org.au
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 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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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.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To identify novel immunological determinants of SVR, the assessment will be by serum assay.
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander Thompson, MD, St Vincent's Hospital Melbourne
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
Other Study ID Numbers
- 032/14 Protocol # :APP106653
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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