Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: Stop current treatment (anti-HBV neucleos(t)ides)Drug: Keep current treatment (anti-HBV neucleos(t)ides)
- Registration Number
- NCT03792919
- Lead Sponsor
- Humanity & Health Medical Group Limited
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- HBsAg positive, HBeAg negative, antibody to HBeAg-positive;
- Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year;
- Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule;
- Patients read, understand the consent form, and signed the study consent.
- Patient with other liver diseases;
- Patient with concurrent hepatitis viruses or HIV infection;
- Patients are reluctant to stop their anti-HBV treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cessation of NAs treatment Stop current treatment (anti-HBV neucleos(t)ides) Chronic hepatitis B patients who meet the criteria to stop the current anti-HBV Neucleos(t)ides treatment will stop their NAs at the baseline of the clinical trial. Keep on current NAs treatment Keep current treatment (anti-HBV neucleos(t)ides) Chronic hepatitis B patients who meet the criteria to stop anti-HBV Neucleos(t)ides treatment will choose to keep on their current NAs treatment from the baseline of the clinical trial.
- Primary Outcome Measures
Name Time Method Incidence of HBsAg clearance From baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of HBsAg clearance during the off-treatment period
- Secondary Outcome Measures
Name Time Method Incidence of Liver failure rom baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of Liver failure during the off-treatment period
Incidence of HBsAg seroconversion From baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of HBsAg seroconversion during the off-treatment period
Incidence of sustain biological response rom baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of sustain biological response during the off-treatment period
Incidence of hepatocellular carcinoma rom baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of hepatocellular carcinoma during the off-treatment period
Incidence of sustain HBV viral submission rom baseline to the end of the fifth year after cessation of anti-HBV treatment. The incidence of sustain HBV viral submission during the off-treatment period
Trial Locations
- Locations (1)
Humanity & Health Research Centre
ðŸ‡ðŸ‡°Hong Kong, Hong Kong SAR, Hong Kong