NCT04684914终止2 期
Phase 2, Double-blind, Randomized, Placebo-controlled Study of HepTcell (Adjuvanted FP-02.2) as an Immunotherapeutic Vaccine in Treatment-naïve Patients With Inactive Chronic Hepatitis B (CHB)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 21
- 主要终点
- The Proportion of Patients Achieving Virologic Responses
研究概览
简要总结
A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels.
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
- Double (Participant, Investigator)
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
- •Men and women 18 to 65 years of age, inclusive
- •Inactive CHB with documented HBsAg positivity for at least 12 months before Day 1
- •qHBsAg ≥ 10 IU/mL but ≤ 100 IU/mL in the 12 months prior to screening
- •HBV DNA ≥ 10 IU/mL at screening
- •AST, ALT, INR, albumin, total bilirubin (excluding patients with Gilbert Syndrome) and direct bilirubin within normal limits at screening
排除标准
- •Positive hepatitis B e antigen (HBeAg) at screening
- •History of a hepatitis B flare or 1-log increase in HBV DNA or HBsAg in the prior 12 months
- •Undetectable HBV DNA at screening
- •Fibroscan > 8.5 kPA at screening, or history of hepatic fibrosis or cirrhosis (NB, a Fibroscan is not required if an examination is performed within 12 months or a liver biopsy was performed within 2 years before Screening and no fibrosis [F1 or greater] was identified).
研究组 & 干预措施
HepTcell
Experimental
Dose administered at intervals of 4 weeks for 6 doses
干预措施: HepTcell (Biological)
Placebo
Placebo Comparator
Dose administered at intervals of 4 weeks for 6 doses
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Patients Achieving Virologic Responses
时间窗: Baseline to Day 169
Virologic response is defined as a 1.0-log reduction in quantitative hepatitis B surface antigen (HBsAg) or serologic clearance of HBsAg from Baseline to Day 169
次要结局
- Changes in HBV DNA Levels(Baseline to Days 85 and 169)
- Changes in Hepatitis B Core-related Antigen (HBCrAg) Levels(Baseline to Days 85 and 169)
- Change in IFN-gamma Frequency by ELISpot Assay in PBMCs(Baseline to Days 85 and 169)
- Changes in Pre-genomic RNA Levels(Baseline to Days 85 and 169)
- The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Surface Antigen (HBsAg) on Day 169(Baseline to Day 169)
- Changes in Quantitative HBsAg Level(Baseline to Days 85 and 169)
- The Proportion of Patients Achieving Serologic Clearance of Hepatitis B Virus (HBV) DNA on Day 169(Baseline to Day 169)
研究者
研究点 (21)
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