NCT00857675已完成3 期
A Multi-Centre, Double-Blind , Randomized, Placebo-Controlled Phase II/III Study of Adefovir Dipivoxil for the Treatment of Chinese Patients With HBeAg Positive Chronic Hepatitis B Followed by Long-Term (5 Years Total) Adefovir Dipivoxil Treatment. (Report on Year 1 and Year 2 Data)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
研究概览
简要总结
The purpose of this study is to determine whether Adefovir Dipivoxil is effective and safe in treatment of Chinese Patients with HBeAg positive Chronic Hepatitis B for 5 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Aged 18-65 years
- •Presence of HBsAg and HBeAg at the time of screening and for at least 6 months prior to screening.
- •Positive HBV DNA plasma assay with screening value equal or more than 10 (6) copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD less than 300 copies/mL) at the time of screening (within 4 weeks of randomisation).
- •Evidence of elevated serum ALT levels defined as serum ALT level greater than or equal to 2.0 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months, and serum ALT levels greater than 1.0 times the ULN at the time of screening.
排除标准
- •Evidence of hepatocellular carcinoma;
- •Clinical signs of liver decompensation;
- •Serum creatinine more than 1.5 mg/dL;
- •ALT more than 10 x ULN; seropositivity for hepatitis C or D virus or HIV;
- •Lamivudine therapy within 3 months prior to screening;
- •ADV therapy or any other anti-HBV therapy within the previous 6 months;
- •Use of systemic antiviral agents, immunomodulators, immunosuppressive therapy, Chinese Traditional Medicines or agents known to lower ALT levels during the study.
研究组 & 干预措施
Adefovir Dipivoxil
Experimental
ADV 10mg tablets once daily
干预措施: AAAA (Drug)
Adefovir Dipivoxil
Experimental
ADV 10mg tablets once daily
干预措施: AAPA (Drug)
Adefovir Dipivoxil
Experimental
ADV 10mg tablets once daily
干预措施: PAAA (Drug)
Adefovir Dipivoxil matched placebo
Placebo Comparator
Adefovir Dipivoxil matched placebo one tablet once daily
干预措施: AAPA (Drug)
Adefovir Dipivoxil matched placebo
Placebo Comparator
Adefovir Dipivoxil matched placebo one tablet once daily
干预措施: PAAA (Drug)
结局指标
主要结局
The log10 reduction in HBV DNA from baseline at week 12 between ADV 10mg and matching placebo
时间窗: Week 12
次要结局
- The proportion of subjects with ALT normalisation(Week 52, 104, 156, 208, 260)
- log10 reduction in serum HBV DNA(Week 52, 104, 156, 208, 260)
- The proportion of subjects with HBV DNA 10(5) copies/mL or a 2 log10 reduction from Baseline HBV DNA level(Week 52, 104, 156, 208, 260)
- The proportion of subjects with HBeAg loss(Week 52, 104, 156, 208, 260)
- The proportion of subjects with HBeAg seroconversion(Week 52, 104, 156, 208, 260)
- The proportion of subjects developing N236T and A181V HBV DNA genotypic mutations associated with ADV resistance(Week 52, 104, 156, 208, 260)
- The proportion of subjects with HBV DNA undetectable (<300 copies/mL)(Week 52, 104, 156, 208, 260)
研究者
研究点 (1)
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