Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorThird Affiliated Hospital, Sun Yat-Sen University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Entecavir or Tenofovir

    Drug

    Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: retreatment1 intervention
Group B: non-retreatment0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
up to 48 weeks

Secondary outcomes

1

occurence of cirrhosis and hepatocellular carcinoma

sign of cirrhosis and hepatocellular carcinoma through ultrasonography

Time frame
up to 48 weeks

Other outcomes

Sponsors and contacts

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