Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Cessation of NAs treatment 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)
Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
|
Active Comparator: Keep on current NAs treatment 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)
Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Humanity & Health Research Centre | Hong Kong | Hong Kong SAR | Hong Kong |
Sponsors and Collaborators
- Humanity & Health Medical Group Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VENI-1