Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Stop current treatment (anti-HBV neucleos(t)ides)
* Drug: Keep current treatment (anti-HBV neucleos(t)ides)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Patient with other liver diseases; Patient with concurrent hepatitis viruses or HIV infection; Patients are reluctant to stop their anti-HBV treatment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to 2 groups. Group 1: Stop current anti-HBV neucleos(t)ides treatment, Group 2: Keep on current anti-HBV nucleus(t)ides treatment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cessation of NAs treatment<br>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. | Drug: Stop current treatment (anti-HBV neucleos(t)ides)<br>* Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.<br>|
| Active Comparator: Keep on current NAs treatment<br>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. | Drug: Keep current treatment (anti-HBV neucleos(t)ides)<br>* Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HBsAg clearance | The incidence of HBsAg clearance during the off-treatment period | From baseline to the end of the fifth year after cessation of anti-HBV treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of HBsAg seroconversion | The incidence of HBsAg seroconversion during the off-treatment period | 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 | 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 | 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 | 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 | rom baseline to the end of the fifth year after cessation of anti-HBV treatment. |