NCT02523547Unknown4 期
PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 134 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The proportion of patients with maintenance of HBV DNA undetectability
研究概览
简要总结
Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
详细描述
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.
排除标准
- •Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)
- •Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)
- •Patient had documented resistance mutations at any time before or at screening
- •Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.
- •Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.
- •Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.
- •Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3
- •Patient is pregnant or breastfeeding or willing to be pregnant
- •Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years
研究组 & 干预措施
Cavir
Experimental
entecavir/0.5mg/day
干预措施: Cavir (Drug)
Baraclude
Active Comparator
entecavir/0.5mg/day
干预措施: Baraclude (Drug)
结局指标
主要结局
The proportion of patients with maintenance of HBV DNA undetectability
时间窗: 48weeks
analysis
次要结局
- The proportion of patients with HBeAg seroconversion(at week 12, 24, 36 and 48 of treatment)
- The proportion of patients with HBeAg seroclearance(at week 12, 24, 36 and 48 of treatment)
- The proportion with HBsAg seroclearance(at week 48 of treatment)
- Changes in HBsAg titer(at week 48 of treatment)
- The proportion with HBeAg seroconversion and HBsAb positive(at week 48 of treatment)
- Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)(at week 48 of treatment)
- Changes in serum HBV DNA levels(at week 48 of treatment)
- Changes in ALanine amino Transferase (ALT)(at week 48 of treatment)
- Proportion of patients with virologic breakthrough(at week 48 of treatment)
研究者
研究点 (1)
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