Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT02581033
Eligibility 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02581033
Study Brief:
Protocol Section:
NCT02581033