RecruitingNCT02883647

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

Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

100 participants

Start Date

Jan 1, 2014

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria5

  • Liver cirrhosis, HCC;
  • Patients with other factors causing active liver diseases;
  • Pregnancy or lactation;
  • Patients with HIV infection or congenital immune deficiency diseases;
  • Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.

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Interventions

DRUGEntecavir or Tenofovir

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


Locations(1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT02883647


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