NCT00869778已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine (Mimogen-based) in Treating Chronic Hepatitis B Patients
Chongqing Jiachen Biotechnology Ltd.15 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 15
- 主要终点
- Percentage of Participants With HBeAg Seroconversion at Endpoint .
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) 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
First stage(0-76 weeks):
Eligible subjects are enrolled and assigned to 3 groups randomly in a 1:1:1 ratio：
- εPA-44 600μg group：Subcutaneous inject εPA-44 600μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- εPA-44 900μg group：Subcutaneous inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
- Placebo control group：Subcutaneous inject empty liposome at week 0, 4, 8, 12, 20, 28；Polyene Phosphatidylcholine Capsules will be taken orally beginning in week 28.
The study cycle consists of screening and enrollment period (week -6-0), treatment period (week 0-28) and follow-up period (week 28-76).
Second stage(76-144 weeks):
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
- •Conforms 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), and HBV-DNA more than 100000 copies/ml;HBeAg (+),HBsAb(-); Alanine aminotransferase（ALT） within 2 to 10 times of ULN (upper limit of normal)
- •HLA-A2 positive
- •Compensatory liver disease having following hematological and biochemical indicators:WBC≥3.5E+9/L; ANC≥1.5E+9/L; PLT≥80E+9/L; Hb≥110g/L; TBil≤1.5ULN; ALB ≥ lower limit of normal value; BUN (Urea)≤upper limit of normal value; Cr≤upper limit of normal value; prothrombin time(PT) elongation≤3 sec; Activated partial thromboplastin time（APTT） within normal value; Fasting blood glucose≤7.0mmol/L
- •TSH within normal value
- •AFP ≤20ng/ml
- •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
- •Antibody of HAV IgM, HCV, HDV IgM or HEV IgM is positive
- •Antibody of CMV IgM, EBV IgM or HIV is positive
- •Antinuclear antibody titer>1:160
- •Hepatocarcinoma, suspected hepatocarcinoma or hepatic cirrhosis
- •Has any of the following illnesses or has a severe disease inappropriate for participation in the study based on the investigator's judgment, such as: 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: bronchiectasis, 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 or metal illness history,etc.
- •Has used anti-HBV drug (Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine) and immunomodulator (Thymic peptide,etc ) 6 months prior to the administration of study medication
- •Has participated in any other drug clinical investigations within the past 3 months
- •Has allergy habitus or has suspected allergy to study drug
- •Female who is in pregnancy, in lactation or planning to become pregnant during the course of the study
- •Has a 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
- •Has a history of organ transplant (except external corneal transplantation and hair transplantation)
- •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
εPA-44 600μg+Placebo 300μg
Experimental
Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
干预措施: εPA-44 (Biological)
εPA-44 600μg+Placebo 300μg
Experimental
Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
干预措施: Placebo (Other)
Placebo 900μg
Placebo Comparator
Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.
干预措施: Placebo (Other)
εPA-44 900μg
Experimental
Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
干预措施: εPA-44 (Biological)
结局指标
主要结局
Percentage of Participants With HBeAg Seroconversion at Endpoint .
时间窗: Endpoint(LOCF), up to 76 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
- Percentage of Participants With HBeAg Seroconversion at Weeks 12, 28, 32, 40, 52, 64, 76(serology response at week 12, 28, 32, 40, 52, 64, 76)
- The Proportion of Patients With Positive Anti-HBe(at week 12, 28, 32, 40, 52, 64, 76.)
- The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 2 Log Scale;(week 12, 28, 32, 40, 52, 64, 76)
- The Proportion of Patients With Serum HBV DNA Load Decrease Equal or Greater Than 1 Log Scale;(week 12, 28, 32, 40, 52, 64, 76)
- Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Weeks 12,28,32,40,52,64,76(week 12, 28, 32, 40, 52, 64, 76)
- The Proportion of Patients With Both Negative HBeAg and HBeAb;(at week 12, 28, 32, 40, 52, 64, 76.)
- Change From Baseline by Visit for HBeAg Titer(at week 12, 28, 32, 40, 52, 64, 76.)
- The Proportion of Patients With Serum HBV DNA Level < 29300 IU / ml;(week 12, 28, 32, 40, 52, 64, 76)
- Change From Baseline by Visit for Serum HBV DNA(week 12, 28, 32, 40, 52, 64, 76)
研究者
研究点 (15)
Loading locations...
相似试验
已完成
2 期
Therapeutic Hepatitis B Vaccine (Mimogen-based) Joint Entecavir in Treating Chronic Hepatitis B PatientsChronic Hepatitis BNCT01326546Chongqing Jiachen Biotechnology Ltd.378
Unknown
2 期
A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis BChronic Hepatitis B Patients With HBeAg-positiveNCT01189656The 458 Hospital of Chinese PLA33
终止
2 期
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis BChronic Hepatitis BNCT00040144Alexion Pharmaceuticals, Inc.85
终止
2 期
A Safety and Efficacy Study of a Single or Double Dose of HEPLISAV™ Hepatitis B Vaccine in Adults With End-Stage Renal DiseaseHepatitis BNCT00498212Dynavax Technologies Corporation41
已完成
2 期
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus InfectionHepatitis B, ChronicNCT00034359Alexion Pharmaceuticals, Inc.79