NCT04939441进行中（未招募）4 期
Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF) in Treatment-Naive CHB Related Fibrosis/Cirrhosis: a 96w Open-label Multicenter Study
Jidong Jia7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Proportion of patients with fibrosis regression
研究概览
简要总结
Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-69 years old (inclusive);
- •BMI (18-30 kg/m2);
- •Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months; or chronic hepatitis B proven by live biopsy;
- •Not received nucleoside (acid) analogue and/or interferon therapy (treatment-naive);
- •Liver biopsy performed within 6 months before treatment and had readable biopsy slides or agrees to have a biopsy performed prior to baseline;
- •METAVIR fibrosis stage ≥ F2;
- •For patients without cirrhosis (F2/3), HBV DNA levels >2000 IU/mL before treatment; For patients with cirrhosis (F4), HBV DNA >20 IU/mL before treatment;
- •ALT≤10 ULN before treatment;
- •Creatinine clearance ≥ 50 mL/min;
- •Agreement not to undertake other HBV systemic antiviral or interferon (IFN) regimens during participation in this study;
- •Willing and able to provide written informed consent.
排除标准
- •Patients with Child-Turcotte-Pugh（CTP）score ≥ 7;
- •Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or liver transplantation;
- •Patients co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis delta virus (HDV), or alcoholic liver diseases, autoimmune liver disease, genetic liver disease, drug-induced liver injury, non-alcoholic fatty liver disease or other chronic liver diseases;
- •Patients with evidence of hepatocellular carcinoma (HCC) by imaging with or without AFP;
- •Patients with other uncured malignant tumors;
- •Patients with organ or bone marrow transplantation;
- •Patients currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion;
- •Patients who are allergic to any component of TAF;
- •Patients who recently or newly started bisphosphate (within 1 month);
- •Patients with active alcohol or drug abuse or history of alcohol or drug abuse (hinder compliance with treatment, or participation in the study or interpretation of results considered by the Investigator);
- •Patients with significant renal, cardiovascular, pulmonary, or neurological disease
- •Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study;
- •Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study;
- •Not suitable for this study identified by researchers.
研究组 & 干预措施
TAF group
Experimental
TAF [Vemlidy® 25mg QD] monotherapy
干预措施: Tenofovir alafenamide (Drug)
结局指标
主要结局
Proportion of patients with fibrosis regression
时间窗: Week 96
Fibrosis stage decrease at least 1 point by Ishak score or "Predominantly Regressive" by "Beijing classification"
HBV DNA undetectable rate
时间窗: Week 96
Serum HBV DNA \<20 IU/mL
次要结局
- Percentage of liver stiffness decrease >= 30%(Week 48 and Week 96)
- ALT normalization rate(Week 48 and Week 96)
- HBeAg and HBsAg loss and seroconversion rate(Week 48 and Week 96)
- Changes in renal function(Week 48 and Week 96)
- HBV DNA undetectable rate(Week 24, Week 48 and Week 72)
- Incidence of liver-related endpoint events(Week 96)
- Changes of bone mineral density(Week 48 and Week 96)
研究者
Jidong Jia
Director of Liver Research Center
Beijing Friendship Hospital
研究点 (7)
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