To Identify the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance among chronic hepatitis B(CHB) patients.
Nucleos(t)ides analogues(NAs) is a safe and effective treatment among chronic hepatitis B(CHB) patients with excellent tolerance. Entecavir or tenofovir mono therapy has been shown to achieve inhibition of HBV replication in almost all adherent patients. However, HBsAg loss rate is low even after long-term NAs treatment. Recent studies indicated that cessation of NAs treatment could increase HBsAg clearance rate. Identifying the collected cases who can stop NAs safely with satisfactory clinical outcome including sustain viral remission and HBsAg clearance is very important.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Humanity & Health Research Centre
Hong Kong, Hong Kong SAR, Hong Kong
RECRUITINGIncidence of HBsAg clearance
The incidence of HBsAg clearance during the off-treatment period
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of HBsAg seroconversion
The incidence of HBsAg seroconversion during the off-treatment period
Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain HBV viral submission
The incidence of sustain HBV viral submission during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of sustain biological response
The incidence of sustain biological response during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of hepatocellular carcinoma
The incidence of hepatocellular carcinoma during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Incidence of Liver failure
The incidence of Liver failure during the off-treatment period
Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
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