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

Humanity & Health Medical Group Limited

Status and phase: Enrolling; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Keep current treatment (anti-HBV neucleos(t)ides); Drug: Stop current treatment (anti-HBV neucleos(t)ides)

Study type: Interventional

Funder types: Other

Identifiers

NCT03792919

VENI-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Cessation of NAs treatment

Experimental group

Description:

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.

Treatment:

Drug: Stop current treatment (anti-HBV neucleos(t)ides)

Keep on current NAs treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Keep current treatment (anti-HBV neucleos(t)ides)