Study on Therapeutic Effects and Safety of Three Types of Nucleotide/Nucleoside Analogues 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
- 300
- 试验地点
- 1
- 主要终点
- Rate of hypercalcemia
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 chronic hepatitis b
详细描述
Chronic hepatitis b (CHB) 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 CHB. This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of CHB.
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;
- •HBeAg-positive: HBV DNA≥20000IU/ml，HBeAg-negative: HBV DNA≥2000IU/ml；
- •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
100 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
100 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
100 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
Rate of hypercalcemia
时间窗: 144 week
The serum calcium would be detected to know the ratio of patients with hypercalcemia.
Rate of renal function decline
时间窗: 144 week
Renal function indicators mainly include blood urea nitrogen, serum creatine and estimated glomerular filtration rate, and the rate of renal function decline would be evaluated.
次要结局
- hepatitis b e antigen seroconversion rate(0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- hepatitis b e antigen loss rate(0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- hepatitis b s antigen loss rate(0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week)
- hepatitis b virus(HBV) DNA undetectable rate(0 week, 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