Chronic Hepatitis B
Conditions
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.
Interventions
DRUGStop current treatment (anti-HBV neucleos(t)ides)
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
DRUGKeep current treatment (anti-HBV neucleos(t)ides)
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
Sponsors
Humanity & Health Medical Group Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. HBsAg positive, HBeAg negative, antibody to HBeAg-positive; 2. Stable administration of anti-HBV neucleos(t)ides analogue mono therapy for at least more than one and a half year; 3. Demonstration of undetectable HBV DNA on three occasions, each at least 6 months apart, which is consistent with the APASL stopping rule; 4. Patients read, understand the consent form, and signed the study consent.
Exclusion criteria
1. Patient with other liver diseases; 2. Patient with concurrent hepatitis viruses or HIV infection; 3. Patients are reluctant to stop their anti-HBV treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 |
Countries
Hong Kong
Contacts
Primary ContactGeorge Lau, MD
Backup ContactDanny Wang
Outcome results
None listed