Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.

Not Applicable

Recruiting

• Conditions: Hepatitis B; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12615001063505
• Lead Sponsor: Professor Alexander Thompson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: Interventional
• Study Design: Not specified