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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- relapse
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
retreatment
- Patients with HBV DNA > 2000 IU/ml and ALT ≥ 5×ULN;
- Patients with HBV DNA > 2000 IU/ml and 2×ULN < ALT ≤ 5×ULN, but have clinical symptoms.
Intervention: Patients of this group will receive Entecavir 0.5mg/d or Tenofovir 300mg/d again.
干预措施: Entecavir or Tenofovir (Drug)
结局指标
主要结局
relapse
时间窗: 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
次要结局
- occurence of cirrhosis and hepatocellular carcinoma(up to 48 weeks)
研究者
Liang Peng
Associated Professor
Third Affiliated Hospital, Sun Yat-Sen University