NCT07204236进行中（未招募）1 期
Study to Evaluate Immunogenicity and Safety of TVAX-008 Injection in Non/Treated Chronic Hepatitis B Patients With HBsAg≤20IU/ml or HBsAg Negative Without Serological Conversion
Grand Theravac Life Sciences (Nanjing) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月18日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from baseline in HBSAb levels after end of treatment
研究概览
简要总结
The objective of this study is to assess the immunogenicity and safety of TVAX-008 injection in antiviral untreated/untreated chronic hepatitis B patients with HBsAg≤20 IU/mL, or HBsAg negative and no seroconversion through an investigator-initiated clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Male or female, aged 18-65 years (inclusive);
- •Chronic hepatitis B patients with HBsAg<20 IU/mL without/on antiviral therapy; or HBsAg negative and no seroconversion population (HBsAg <20 IU/mL;HBVDNA<20 IU/mL; ）
- •HBsAg <10mIU/mL detected at least 4 weeks
排除标准
- •Use of immunosuppressants within 6 months prior to first dose:
- •Use of c1orticosteroids (other than topical or inhaled corticosteroids) for 1 week or more within 6 months prior to the first dose;
- •Hepatitis C virus (HCV), hepatitis D virus (HDV), Treponema pallidum (TP) antibody or human immunodeficiency virus (HIV) antibody positive:
研究组 & 干预措施
TVAX-008
Experimental
TVAX-008
干预措施: TVAX-008 (Drug)
结局指标
主要结局
Change from baseline in HBSAb levels after end of treatment
时间窗: week24
Change from baseline in HBSAb levels after end of treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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