Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Survival rate in the follow-up
研究概览
简要总结
This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.
详细描述
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- •Age from 12 to 65 years old;
- •Serum total bilirubin level > 10 times upper limit of normal;
- •Prothrombin time activity < 40% or prothrombin time international ratio > 1.5；
- •Do not receive nucleotide/nucleoside analogues treatment in the past half year.
排除标准
- •Other active liver diseases;
- •Hepatocellular carcinoma or other malignancy;
- •Pregnancy or lactation;
- •Human immunodeficiency virus infection or congenital immune deficiency diseases;
- •Severe diabetes, autoimmune diseases;
- •Other important organ dysfunctions;
- •Using glucocorticoid;
- •Patients can not follow-up;
- •Investigator considering inappropriate.
研究组 & 干预措施
ETV group
50 patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day from baseline to life-long.
干预措施: Entecavir (Drug)
TDF group
50 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to life-long.
干预措施: Tenofovir Disoproxil Fumarate (Drug)
TAF group
50 patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day from baseline to life-long.
干预措施: Tenofovir Alafenamide (Drug)
结局指标
主要结局
Survival rate in the follow-up
时间窗: 144 week
Whether patients will survive after treatment is observed in the follow-up.
次要结局
- Model for end-stage liver disease (MELD) score is recorded after treatment(0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Ratio of patients with undetectable hepatitis b virus DNA after treatment(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
研究者
Liang Peng
Professer
Third Affiliated Hospital, Sun Yat-Sen University