Chronic Hepatitis b
Conditions
Keywords
chronic hepatitis b, nucleos(t)ide analog
Brief 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.
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
Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| occurence of cirrhosis and hepatocellular carcinoma | up to 48 weeks | sign of cirrhosis and hepatocellular carcinoma through ultrasonography |
Countries
China
Contacts
Primary ContactWenxiong Xu, Master
Backup ContactLiang Peng, Doctor
Outcome results
None listed