Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues in Patients With Hepatitis b Virus Related Compensated Cirrhosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of decompensated cirrhosis
研究概览
简要总结
This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.
详细描述
Hepatitis b virus infection remains a serious public health problem 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 hepatitis b virus related compensated cirrhosis. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.
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
- 18 Years 至 65 Years（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 18 to 65 years old;
- •Hepatitis b virus DNA positive;
- •Cirrhosis or portal hypertension is found through ultrasonography, computed tomography or magnetic resonance imaging;
- •Do not receive nucleotide/nucleoside analogues treatment in the past half year.
排除标准
- •Complications of decompensated cirrhosis: ascites, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, etc;
- •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
Incidence of decompensated cirrhosis
时间窗: 144 week
Incidence of decompensated cirrhosis is evaluated in the follow-up
次要结局
- 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)
- Ratio of patients with hepatitis b virus e antigen seroconversion after treatment(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Blood urea nitrogen(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Ratio of patients with undetectable hepatitis b virus surface antigen after treatment(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Serum calcium(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Serum phosphorus(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Serum creatinine(4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- Estimated glomerular filtration rate(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