NCT02588937Unknown4 期
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 76
- 试验地点
- 9
- 主要终点
- The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
研究概览
简要总结
The purpose of this study is to evaluate the antiviral activity and safety of EntecaBell ODT. in chronic hepatitis B Patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 20 years old
- •Patients with Chronic Hepatitis B diagnosed
- •Patients who show positive HBsAg
- •Patients who show positive HBeAg or negative HBeAg
- •Patients who showed HBV DNA undetected(less than 300 copies/mL)
- •Patients who have administered Baraclude Tab. 0.5mg for 1~4 years
- •Patients who showed ALT less than 5 times of the upper limit in the normal range
- •Patient who decided to participate and signed on an informed consent form willingly
排除标准
- •Patients who have hepatitis C (HCV), hepatitis D (HDV), or human immunodeficiency virus (HIV)
- •Patients with a uncompensated liver disease who have at least one of the following values or signs
- •Total bilirubin > 2.5mg/dl
- •Prothrombin time delayed more than three seconds of upper limit in the normal range
- •Serum Albumin < 3 g/dL
- •A medical history of ascites, jaundice, hemorrhage by varix, hepatic encephalopathy, or other signs of liver function loss
- •Patients who are estimated to have hepatocellular carcinoma (HCC) through imaging examination or showed alpha-fetoprotein(AFP) more than 100 ng/mL
- •Patients who showed Creatinine Clearance < 50 mL/min by calculating Cockcroft-Gault equation
- •Patients who were not administered any anti-viral agents except Baraclude Tab.(Entecavir)
- •Administration of other Investigational Product within 30 days
- •History of malignant tumor within 5 years (including leukemia and lymphoma)
- •Patients who have a severe disease, such as heart failure, renal failure, and pancreatitis, decided by an investigator to have an effect on this clinical trial
- •Patients who have other hepatic diseases except hepatitis B
- •Administration immunosuppressants or corticosteroids over 2 weeks within 24 weeks
- •Patients who have to administer immunosuppressants or Nephrotoxic drugs, Hepatotoxic drugs for period of Clinical Trial
- •Pregnant, breast-feeding and childbearing age who don't use adequate contraception
- •Patients who are possible to decline daily function due to a mental disease or patients who are not able to understand the purpose and methods of this clinical trial
- •Patients who received an organ transplant or are going to received an organ transplant
- •Severe hypersensitivity to Entecavir
- •Another clinical condition in investigator's judgement
研究组 & 干预措施
EntecaBell ODT.
Experimental
干预措施: EntecaBell ODT. 0.5mg (Drug)
Baraclude Tab.
Active Comparator
干预措施: Baraclude Tab. 0.5mg (Drug)
结局指标
主要结局
The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)
时间窗: 48 week
次要结局
- The Difference between the baseline and at the 24, 48 week of HBV DNA level(log10)(24, 48 week)
- The rate of subjects who showed HBsAg serum loss(48 week)
- The rate of subjects who showed HBsAg seroconversion(48 week)
- The rate of subjects who showed Virologic breakthrough(12, 24, 48 week)
- The rate of subjects who showed HBeAg serum loss(24, 48 week)
- The rate of subjects who showed HBeAg seroconversion(24, 48 week)
- The rate of subjects who showed HBV DNA undetected (less than 300copies/mL)(24 week)
研究者
研究点 (9)
Loading locations...
相似试验
终止
3 期
A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B InfectionChronic Hepatitis BNCT00605384Bristol-Myers Squibb4
已完成
3 期
Continue Entecavir Rollover From ChinaChronic Hepatitis B VirusNCT00975091Bristol-Myers Squibb600
已完成
4 期
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) InfectionHepatitis B InfectionNCT00371150Bristol-Myers Squibb131
已完成
3 期
Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B InfectionChronic DiseaseHepatitis BNCT00096785Bristol-Myers Squibb69
已完成
3 期
Induction/Simplification With Atazanavir + Ritonavir + Abacavir/Lamivudine Fixed-Dose Combination In HIV-1 InfectionInfection, Human Immunodeficiency Virus IHIV InfectionNCT00440947ViiV Healthcare515