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Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in Hepatitis B Patients (STOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by St Vincent's Hospital Melbourne
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Alexander Thompson, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier:
NCT02581033
First received: October 15, 2015
Last updated: October 18, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention
Chronic Hepatitis B.
Drug: Nucleoside Analogue therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determinants of Sustained Virological Response After Discontinuation of Long-term Nucleoside Analogue Therapy in Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital Melbourne:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Nucleoside Analogue therapy
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Other Name: Cessation of Nucleoside Analogue Therapy

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02581033

Contacts
Contact: Gareth Burns, MD +61309231 3581 gareth.burns@svha.org.au

Locations
Australia, Victoria
St Vincent's Hospital Recruiting
Melbourne, Victoria, Australia, 3065
Contact: Gareth Burns, MD    +61392313581    gareth.burns@svha.org.au   
Contact: John Gough, RN    +61392313518    john.gough@svha.org.au   
Sponsors and Collaborators
St Vincent's Hospital Melbourne
National Health and Medical Research Council, Australia
Investigators
Principal Investigator: Alexander Thompson, MD St Vincent's Hospital Melbourne
  More Information

Responsible Party: Alexander Thompson, Professor, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT02581033     History of Changes
Other Study ID Numbers: 032/14 Protocol # :APP106653 
Study First Received: October 15, 2015
Last Updated: October 18, 2015
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 23, 2016