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Recruiting NCT03792919

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

Phase IV Interventional Chronic Hepatitis B

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stop current treatment (anti-HBV neucleos(t)ides), Keep current treatment (anti-HBV neucleos(t)ides).
Who it may be relevant to
Registry conditions: Chronic Hepatitis B. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

  • 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.
  • 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.

Primary outcome measures

  • Incidence of HBsAg clearance [Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.]
Secondary outcome measures (5)
  • Incidence of HBsAg seroconversion [Time frame: From baseline to the end of the fifth year after cessation of anti-HBV treatment.]
  • Incidence of sustain HBV viral submission [Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
  • Incidence of sustain biological response [Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
  • Incidence of hepatocellular carcinoma [Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]
  • Incidence of Liver failure [Time frame: rom baseline to the end of the fifth year after cessation of anti-HBV treatment.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Humanity & Health Research Centre — Hong Kong

Identifiers

NCT: NCT03792919 · VENI-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗