NCT01326546已完成2 期
A Randomized, Double-blind, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating HBeAg Positive Chronic Hepatitis B Patients
Chongqing Jiachen Biotechnology Ltd.15 个研究点 分布在 1 个国家目标入组 378 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 15
- 主要终点
- Percentage of Participants With HBeAg Seroconversion at Week 48
研究概览
简要总结
The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.
详细描述
Eligible subjects are enrolled and assigned into 2 groups randomly with a 1:1 ratio：
- Therapeutic HBV vaccine Joint Entecavir group：Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day ；
- Empty liposome Joint Entecavir group：Inject empty liposome at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 + Oral intake entecavir 0.5mg per day.
The study cycle consists of screening and enrollment period (week -4～0), treatment and follow-up period (week 0-96).
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
- Quadruple (Participant, Care Provider, 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, male or female;
- •Conforming to diagnosis standard of chronic hepatitis B according to " 2005 Guideline for Prevention and Treatment of Hepatitis B " , (with positive HBsAg for more than 6 months), never have systemic treatment of anti-HBV viral ,and
- •HBV-DNA ≥ 1.72×10^4 IU/ml；
- •HBeAg (+), HBeAb (-)；
- •ALT within 2 to 10 times of ULN (upper limits of normal);
- •HLA-A2 positive;
- •Compensatory liver disease having following hematological and biochemical parameters:
- •WBC ≥ 3.5×10^9/L;
- •ANC ≥ 1.5×10^9/L;
- •PLT ≥ 80×10^9/L;
- •Hb ≥ 100g/L;
- •TBil ≤ 1.5 ULN;
- •ALB not lower than low limit of normal value;
- •BUN no more than high limit of normal value;
- •Cr ≤ 1.5 ULN high limit of normal value;
- •PT elongation ≤ 3 sec, APTT in normal value;
- •Fasting blood glucose ≤ 7.0mmol/L;
- •TSH in normal value;
- •AFP test result no more than high limit of normal value;
- •Take effective contraception for subject with child-bearing potential (including females and female partners of males);
- •Understand and sign ICF approved by EC;
- •Willing to comply with the study procedures and complete the study.
排除标准
- •Antibodies of HCV, HDV or HIV is positive;
- •ANA titer > 1:100;
- •Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
- •Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc;
- •Respiratory system: bronchiectasia, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc;
- •Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc;
- •Others: autoimmune disorder, active tuberculosis, malignancies (e.g.: tumor), neuropathic, metal, acute or chronic pancreatitis illness history, etc.
- •Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
- •Have allergic diathesis or have suspected allergy to εPA-44;
- •Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;
- •Have history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence;
- •Have history of organ transplantation (except corneal transplantation and hair transplantation);
- •Have participated in any other drug clinical investigations within 3 months;
- •Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.
研究组 & 干预措施
Therapeutic HBV vaccine+Entecavir
Experimental
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
干预措施: Therapeutic HBV vaccine (Biological)
Therapeutic HBV vaccine+Entecavir
Experimental
Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
干预措施: entecavir (Drug)
placebo+Entecavir
Placebo Comparator
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
干预措施: entecavir (Drug)
placebo+Entecavir
Placebo Comparator
Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.
干预措施: placebo (Other)
结局指标
主要结局
Percentage of Participants With HBeAg Seroconversion at Week 48
时间窗: 48 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
- Serological Response(96 weeks)
- Virological Response(96 weeks)
- Biochemistry Response(96 weeks)
- Histological Response(72 weeks)
研究者
研究点 (15)
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