Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 9
- 主要终点
- The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
研究概览
简要总结
The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.
详细描述
Second stage(76-144 weeks):
In this follow-up stage the trial is open designed, and all the subjects completed the first stage study(0-76 weeks)
- Subjects with virological response but no serological response/with serological response but no virological response/neither virological nor serological response in the first stage, and be willing to continue the this follow-up study, will be treated by εPA-44 900 μg at week 80,83,86,89,92,95,98,101,104,108,112,116,120,124,128.
- Subjects with both virological and serological response, will be followed-up to 144 weeks with no Adefovir Dipivoxil or εPA-44 900 μg treatment.
The definition of response as below:
- Virological response: HBV DNA<2.93×10∧3IU/ml at 76 weeks;
- Serological response: serological conversion of HBeAg at 76 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects completed the first stage study(0-76 weeks) and willing to willing to participate in the trial
- •Uses effective contraception for subject with child-bearing potential (including females and female partners of males)
- •Understands and signs ICF approved by EC
- •Willing to comply with the study procedures and complete the study
排除标准
- •1.Any other factors inappropriate for enrollment in the study or study completion in the view of the investigator
研究组 & 干预措施
Follow-up group-placebo
These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
Follow-up group-εPA-44 600μg
These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
Follow-up group-εPA-44 900μg
These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
εPA-44 900μg group-placebo
These subjects from the placebo group of protocol 71006.01 InjectεPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
干预措施: εPA-44 (Biological)
εPA-44 900μg group-εPA-44 600μg
These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
干预措施: εPA-44 (Biological)
εPA-44 900μg group-εPA-44 900μg
These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
干预措施: εPA-44 (Biological)
结局指标
主要结局
The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at the End of the Follow-up Period
时间窗: Endpoint (LOCF), up to 144 weeks
Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)
次要结局
- Change From Baseline by Vsit for HBeAg Titer.(week95,108,120,144)
- The Proportion of Patients With Both Negative HBeAg and HBeAb.(week95,108,120,144)
- The Proportion of Patients With Both Negative HBsAg and HBsAb.(week95,108,120,144)
- The Proportion of Patients With HBV DNA Levels Undetectable or Below the Detection Limit(week95,108,120,144)
- Change From Baseline by Visit for Serum HBV DNA(week95,108,120,144)
- The Proportion of Patients About HBsAg / Anti-HBs Seroconversion at Week 95,108,120,144(week95,108,120,144)
- The Proportion of Patients About HBeAg / Anti-HBe Seroconversion at week95,108,120,144(week95,108,120,144)
- Percentage of Participants Who Achieved HBV DNA Levels <29300 IU/mL or HBV DNA Load Decrease Equal or Greater Than 2 Log Scales;(week95,108,120,144)