The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- 60-day survival rate of patients (%)
研究概览
简要总结
This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.
详细描述
NAs drugs play an important role in the treatment of HBV-ACLF. Currently, multiple research results indicate that the use of NAs can significantly improve the prognosis of HBV-ACLF patients, and the rapid decrease in early viral load is closely related to better prognosis. Compared to ETV and TDF, two early marketed NAs drugs, there is limited research on the prognosis and safety of TAF and TMF in HBV-ACLF patients, and head to head studies on the treatment of HBV-ACLF with various commonly used NAs drugs are even rarer. In addition, how novel virological markers change in HBV-ACLF patients after NAs treatment and whether there is a correlation with patient prognosis is also an unexplored topic. Therefore, this study aims to analyze the changes in clinical indicators and viral markers in HBV-ACLF patients during hospitalization, combined with the patient's prognosis, to explore the dynamic changes of novel virological markers during HBV-ACLF treatment, as well as the safety and impact of different NAs drugs on the prognosis of HBV-ACLF treatment.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatitis B surface antigen positive ≥ 6 months;
- •TBil>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA < 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL))
排除标准
- •Patients with malignant liver tumors and other tumors;
- •Pregnant or lactating women;
- •Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease;
- •Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
- •Patients with other organ dysfunction or failure;
- •Combined using more than one NAs drug
研究组 & 干预措施
ETV group
HBV-ACLF patients treated with ETV after admission
TAF group
HBV-ACLF patients treated with TAF after admission
TMF group
HBV-ACLF patients treated with TMF after admission
结局指标
主要结局
60-day survival rate of patients (%)
时间窗: 60 days
Survival status of patients 60 days after admission
次要结局
- 24-week HBV DNA negativity rate (%)(24 weeks)
研究者
Meifang Han
Professor of Department of Infectious Diseases
Tongji Hospital