About this trial
The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients received anti-HBV therapy with nucleos(t)ide analogs.
Last anti-HBV therapy should continue for at least 2 years.
For HBeAg positive patients, HBV DNA should keep negative for at least 1 year after HBeAg seroconversion before the therapy ending; for HBeAg negative patients, HBV DNA should keep negative for at least 2 years before the therapy ending.
Disqualifiers
Liver cirrhosis, HCC;
Patients with other factors causing active liver diseases;
Pregnancy or lactation;
Patients with HIV infection or congenital immune deficiency diseases;
Trial population
patients of chronic hepatitis b
Trial design
Cohort
Prospective
Treatments tested in this trial
Entecavir or Tenofovir
DrugPatients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
Treatment groups
Trial outcomes
Primary outcomes
relapse
non-relapse:serum HBV DNA \< 2000 IU/ml; virologic relapse: serum HBV DNA \> 2000 IU/ml; clinical relapse:serum HBV DNA \> 2000 IU/ml and ALT \> 2×ULN
Secondary outcomes
occurence of cirrhosis and hepatocellular carcinoma
sign of cirrhosis and hepatocellular carcinoma through ultrasonography
Sponsors and contacts
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