Clinical trial NCT03792919: Cessation of Long Term NAs vs. Keeping on NAs Among CHB Patients (CNAVK)
Official title: Virological Response After Cessation of Long Term Anti-HBV Nucleos(t)Ide Analogues (NAs) vs. Keeping on NAs Among Chronic Hepatitis B (CHB) Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Humanity & Health Medical Group Limited
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of HBsAg clearance
timeFrame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
Secondary outcomes:
measure: Incidence of HBsAg seroconversion
timeFrame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.
measure: Incidence of sustain HBV viral submission
timeFrame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
measure: Incidence of sustain biological response
timeFrame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
measure: Incidence of hepatocellular carcinoma
timeFrame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
measure: Incidence of Liver failure
timeFrame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Humanity & Health Research Centre
state: Hong Kong SAR
Study officials:
References: