HBeAg negative chronic hepatitis B MedDRA version: 20.1 Level: PT Classification code 10052297 Term: Hepatitis B e antigen negative System Organ Class: 10022891 - Investigations
Conditions
Interventions
Trade Name: Tenofovir disoproxilfumarate
Product Name: Tenofovir disoproxil
Pharmaceutical Form: Tablet
Trade Name: Entecavir
Product N
Sponsors
Oslo University Hospital HF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults (18-70 years) with HBeAg negative chronic hepatitis B - HBeAg negative at start of antiviral therapy - Treated minimum 2 years with either tenofovir or entecavir without interruption - Full viral suppression >2 years: at least 3 measurements at least 6 months apart with at least 24 months between the first and last measurement. - Most recent liver fibrosis assessment, performed within the past 12 months, does not show advanced fibrosis (i.e. Metavir score =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - A history of decompensated liver disease, either by clinical signs (ascites, encephalopathy, portal hypertension, jaundice) or suggestive laboratory results (total bilirubin >38 umol/L, INR >1.5, platelets 12 kPa). Elastography readings with concomitant ALT >200 U/L are not considered. - Previous HCC - Co-infections with HIV, hepatitis C or hepatitis D - Other disease or medication that can interfere with the study (e.g. ongoing alcohol or illicit drug abuse, immunosuppressive medication, other active liver disease, or any other condition which in the opinion of the physician is incompatible with participation)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: To study whether stopping NA therapy – and delaying re-start - can trigger an immune response and set off a functional cure (i.e. HBsAg loss) ;Primary end point(s): HBsAg loss within 3 years after stopping NA therapy;Timepoint(s) of evaluation of this end point: 3 years after stopping NA therapy; Secondary Objective: Assess whether stopping NA therapy – and delaying re-start - leads to a longer time off treatment and shorter time to HBsAg loss -Assess the safety of stopping NA therapy – and delaying re-start - in terms of hepatic decompensation, fibrosis progression, and/or adverse events -Study whether stopping NA therapy – and delaying re-start – leads to a higher chance of sustained off-therapy immune control (low viral load and normal ALT) -Assess the effect of stopping NA therapy – and delaying start - on quality of life -Assess the cost-effectiveness of stopping NA therapy – and delaying re-start -Identify predictors of HBsAg loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to HBsAg loss -Time to restart of antiviral therapy -Adverse events -Changes in liver fibrosis measured by elastography -Sustained off-therapy response viz HBV DNA <2000 IU/ml and ALT <40 U/L -Changes in quality of life -Cost-effectiveness ;Timepoint(s) of evaluation of this end point: ???? | — |
Countries
Ethiopia, Sweden
Contacts
Public ContactAsgeir Johannessen
Oslo University Hospital
Outcome results
None listed