Entecavir or Tenofovir: Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients received anti-HBV therapy with nucleos(t)ide analogs.
2. Last anti-HBV therapy should continue for at least 2 years.
3. 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.
Exclusion Criteria:
1. Liver cirrhosis, HCC;
2. Patients with other factors causing active liver diseases;
3. Pregnancy or lactation;
4. Patients with HIV infection or congenital immune deficiency diseases;
5. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.
Primary outcome measure(s)
relapse — up to 48 weeks 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
Trial sites (1)
Facility
City
Region
Status
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
More Third Affiliated Hospital, Sun Yat-Sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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