Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- hepatitis b s antigen decrease from baseline
研究概览
简要总结
This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
详细描述
Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 and hepatitis b antibody > 0.5 year;
- •Age from 18 to 65 years old;
- •Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
- •Positive Hepatitis b virus(HBV);
- •Do not receive nucleotide/nucleoside analogues or interferon 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; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.
研究组 & 干预措施
TAF group
100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss.
干预措施: Tenofovir alafenamide Fumarate (Drug)
结局指标
主要结局
hepatitis b s antigen decrease from baseline
时间窗: 48 week, 96 week, 144 week
Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144.
次要结局
- hepatitis b virus(HBV) DNA undetectable rate(48 week, 96 week, 144 week)
- hepatitis b virus(HBV) RNA undetectable rate(48 week, 96 week, 144 week)
- hepatitis b s antigen loss rate(48 week, 96 week, 144 week)
- hepatitis b e antigen loss rate(48 week, 96 week, 144 week)
研究者
Liang Peng
Professer
Third Affiliated Hospital, Sun Yat-Sen University