Evaluate the Efficacy and Safety of Switching to Tenofovir Disoproxil From Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients Who Pretreated With Tenofovir Disoproxil Fumarate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- HBV DNA inhibition
研究概览
简要总结
This study evaluates the efficacy and safety of switching to Tenofovir Disoproxil from Tenofovir Disoproxil Fumarate in Chronic Hepatitis B Patients who pretreated with Tenofovir Disoproxil Fumarate.
In Open-Label, phase 3 studies, we randomly assigned patients with hepatitis B e antigen (HBeAg)-negative or HBeAg-positive chronic HBV infection to receive Tenofovir Disoproxil or Tenofovir Disoproxil Fumarate (ratio, 2:1) once daily for 48 weeks
详细描述
Tenofovir Disoproxil and Tenofovir Disoproxil Fumarate is a nucleotide analogue and a potent inhibitor of human immunodeficiency virus type 1 reverse transcriptase and hepatitis B virus (HBV) polymerase.
The primary efficacy end point at week 48 of this study was defined as the combination of an HBV DNA level of less than 400 copies per milliliter and histologic improvement .
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
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for at least 6 months.
- •HBeAg negative and HBeAb positive at screening
排除标准
- •Pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study
- •Males and females of reproductive potential who are unwilling to use an effective method of contraception during the study.
- •Decompensated liver disease defined as conjugated bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mL, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
- •Significant renal, cardiovascular, pulmonary, or neurological disease
- •currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
研究组 & 干预措施
Tenofovir Disoproxil
Tenofovir Disoproxil 245mg, a daily dose for 48 weeks
干预措施: Tenofovir Disoproxil (Drug)
Tenofovir Disoproxil Fumarate
Tenofovir Disoproxil Fumarate 300mg, a daily dose for 48 weeks
干预措施: Tenofovir Disoproxil Fumarate (Drug)
结局指标
主要结局
HBV DNA inhibition
时间窗: 48weeks
plasma HBV DNA level of less than 400 copies per milliliter
次要结局
- viral suppression(24weeks)