Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Entecavir or Tenofovir.
- Who it may be relevant to
- Registry conditions: Chronic Hepatitis b. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
Patients with chronic hepatitis b were enrolled in the study. Age, sex, weight, height, symptoms (e.g., fatigue, poor appetite, jaundice), relapse, retreatment, occurrence of liver cirrhosis and hepatocellular carcinoma (HCC), mortality and survival rate were recorded in the study. We also observed the laboratory tests including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBIL), blood urea nitrogen (BUN), creatine, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus (HBV) DNA, CD4 positive T lymphocyte (CD4+T), CD8 positive T lymphocyte (CD8+T), Type 1 helper T lymphocyte (Th1), Type 2 helper T lymphocyte (Th2),fibroscan and B ultrasound. If clinical relapse occurred, patients were retreated with nucleos(t)ide analogs.
Interventions
- Drug Entecavir or Tenofovir
Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
Primary outcome measures
- relapse [Time frame: up to 48 weeks]
Secondary outcome measures (1)
- occurence of cirrhosis and hepatocellular carcinoma [Time frame: up to 48 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
Publications
- Wu L, Lai J, Luo Q, Zhang Y, Lin C, Xie D, Chen Y, Deng H, Gao Z, Peng L, Xu W. Long-term hepatitis B surface antigen kinetics after nucleos(t)ide analog discontinuation in patients with noncirrhotic chronic hepatitis B. Liver Res. 2024 Jul 6;8(3):179-187. doi: 10.1016/j.livres.2024.07.001. eCollection 2024 Sep. PMID 39957751
- Xu WX, Zhang Q, Zhu X, Lin CS, Chen YM, Deng H, Mei YY, Zhao ZX, Xie DY, Gao ZL, Xie C, Peng L. 48-Week Outcome after Cessation of Nucleos(t)ide Analogue Treatment in Chronic Hepatitis B Patient and the Associated Factors with Relapse. Can J Gastroenterol Hepatol. 2018 May 10;2018:1817680. doi: 10.1155/2018/1817680. eCollection 2018. PMID 29862225
Identifiers
NCT: NCT02883647 · PL