NCT00513968已完成1 期
A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Adverse events and clinical laboratory abnormalities
研究概览
简要总结
This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
- •Chronic hepatitis B infected patient with positive HBeAg at screening
- •Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
- •HBV DNA more than 1x10^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
- •Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
- •Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
- •Patient given a written consent voluntarily
排除标准
- •Have uncompensated liver disease
- •Serum creatinine > ULN x 1.5
- •Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
- •Had a previous liver or bone marrow transplant
- •Are currently taking any immunosuppressant or any possible immune modulatory drugs
- •Women who are pregnant or breastfeeding
- •Woman or man who plans a birth for study duration
- •Any experience of severe adverse drug reaction or any medical history of severe allergic disease
- •Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
- •Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
- •Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
- •Patient with any present malignant tumor except liver or its history
- •Other inappropriate patient in discretion of investigator
研究组 & 干预措施
I
Experimental
HB-110 2mg, 4mg or 8mg combined with Adefovir
干预措施: a mixed plasmid DNA (HB-110) (Genetic)
II
Active Comparator
Adefovir
干预措施: Adefovir (Drug)
结局指标
主要结局
Adverse events and clinical laboratory abnormalities
时间窗: 48 weeks
次要结局
- HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity(24, 28, 32, 42, 44, and 48 week)
研究者
研究点 (1)
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