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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cessation of NAs treatment | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stop current treatment (anti-HBV neucleos(t)ides) | Drug | Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| George Lau, MD | Contact | 852-28613777 | gkklau@netvigator.com | |
| Danny Wang | Contact | 852-28613777 | danny.wang@hnhmgl.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanity & Health Research Centre | Recruiting | Hong Kong | Hong Kong SAR | Hong Kong |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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
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| Keep current treatment (anti-HBV neucleos(t)ides) | Drug | Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment. |
|
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. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |