Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 9
- 主要终点
- Compared with baseline, decline of serum HBV-DNA in the value
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
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
- Double (Participant, Investigator)
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
- •Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- •Aged 18 to 70 years old，male or female
- •Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
- •1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
- •Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
- •Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
- •WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
- •Creatinine (Cr) ≤ 1.5 × ULN.
- •If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
- •Patients signed an informed consent form and compliance was good.
排除标准
- •Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
- •Patients with cirrhosis or liver cancer.
- •Patients have participated in another therapeutic clinical trial in 3 months.
- •Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
- •Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- •Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
- •Pregnant woman, lactating women or those who wre allergic for study drug.
研究组 & 干预措施
HBeAg positive group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Entecavir maleate tablets (Drug)
HBeAg positive group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: blank Baraclude tablets (Drug)
HBeAg positive group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Blank maleate entecavir tablets (Drug)
HBeAg positive group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Baraclude tablets (Drug)
HBeAg-negative group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Entecavir maleate tablets (Drug)
HBeAg-negative group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: blank Baraclude tablets (Drug)
HBeAg-negative group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Blank maleate entecavir tablets (Drug)
HBeAg-negative group
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
干预措施: Baraclude tablets (Drug)
结局指标
主要结局
Compared with baseline, decline of serum HBV-DNA in the value
时间窗: 5 years
次要结局
未报告次要终点