Clinical trial Recruiting at 1 site Observational Ages 18 to 65

Observing effects after stopping hepatitis B treatment

Official title: 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

Run by Third Affiliated Hospital, Sun Yat-Sen University · NCT02883647 · Data updated 2026-11-12

This study looks at what happens to people with chronic hepatitis B after they stop their treatment to see how their health changes over time.

Quick facts

Study typeObservational
Ages18 Years to 65 Years
SexAll
Enrollment100 (estimated)
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedJanuary 1, 2014
Main results expectedDecember 31, 2024
Study endsDecember 31, 2024
Registry record updatedNovember 29, 2024
Trial IDNCT02883647 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients who have been on nucleos(t)ide analog therapy for at least two years and meet specific virological criteria.

Probably not a fit

Patients with liver cirrhosis, hepatocellular carcinoma, or other significant liver diseases will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study observes the therapeutic effects and long-term outcomes in patients with chronic hepatitis B after they discontinue treatment with nucleos(t)ide analogs. It involves monitoring various health parameters, including symptoms, laboratory test results, and the occurrence of liver-related complications. The study aims to assess the relapse rates and the need for retreatment in these patients over time.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term management of chronic hepatitis B after therapy cessation.

How similar studies have gone: While there have been studies on hepatitis B treatment, this specific observational approach focusing on post-therapy outcomes is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • The Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

  • Principal investigator: Liang Peng, Doctor — Third Affiliated Hospital, Sun Yat-Sen University
  • Study coordinator: Wenxiong Xu, Master
  • Email: xwx1983@163.com
  • Phone: +8613760783281

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.