NCT04539652已完成4 期
A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Rate of subjects with HBV DNA less than 20 IU/mL
研究概览
简要总结
This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who show positive HBsAg
- •Patients who show positive or negative HBeAg
排除标准
- •Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
- •Patients with a history of allergic reaction to Tenofovir
- •Patients who are unable to participate in clinical trials based on investigator's decision.
研究组 & 干预措施
Experimental group
Experimental
干预措施: Experimental (Drug)
结局指标
主要结局
Rate of subjects with HBV DNA less than 20 IU/mL
时间窗: change after 48 weeks compared to baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Efficacy and Tolerance of Naked DNA Vaccine in Patients With Chronic B HepatitisChronic Hepatitis BNCT00536627French National Agency for Research on AIDS and Viral Hepatitis70
已完成
不适用
Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult PatientsChronic Hepatitis BNCT01267162Medical Procare PLLC31
已完成
4 期
A Randomized,Parallel-group Clinical Trial of Hepatitis B Vaccine With Different Dosages and Schedules in Healthy AdultsHepatitis BNCT02203357Peking University353
Unknown
2 期
A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis BChronic Hepatitis B Patients With HBeAg-positiveNCT01189656The 458 Hospital of Chinese PLA33
已完成
1 期
Safety of HEPLISAV™ Hepatitis B Virus Vaccine in End-stage Kidney Failure PatientsHepatitis BNCT00426712Dynavax Technologies Corporation42