jRCTs061210087招募中不适用
phase II clinical trial of a therapeutic vaccine containing HBs/HBcAg for HBV carriers without ongoing anti-HBV treatment (HepBVac-P2ASC)
未提供0 个研究点目标入组 200 人开始时间: 2022年6月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •HBV carriers who fulfill the inclusion criteria below
- •(1) 20-85 years old
- •(2) Positive for HBsAg or HBV-DNA
- •(3) Not under nucleos(t)ide analogue or interferon treatment
- •(4) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS: 0-2)
- •(5) No evidence of organ dysfunction
- •Liver: Child-Pugh Score less than 9
- •Kidney: eGFR more than 30
- •Heart: No severe heart failure by interview
- •Lung: SpO2 above 90% in room air
排除标准
- •(1) Allergic history of past vaccination
- •(2) Pregnant, unwilling to practice contraception during the study or lactating female
- •(3) Severe complication (malignant hypertension, severe congestive heart failure, severe liver failure, poorly controlled diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonia)
- •(4) Bearing malignant carcinoma including HCC
- •(5) Severe mental disability
- •(6) Positive for HCV-RNA
- •(7) Taking immunosuppressive drugs, steroid, interferon prior 90 days
- •(8) Taking nucleos(t)ide analogues
- •(9) Inappropriate to participate in this trial
结局指标
主要结局
-
amount of HBsAg reduction HBsAg loss (below 0.005 IU/mL by CLEIA) rate
次要结局
未报告次要终点
研究者
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