JPRN-jRCTs061210086招募中2 期
phase 2 clinical trial of a therapeutic vaccine containing HBs/HBc antigen for chronic hepatitis B patients under nucleos(t)ide analogue treatment: a multicentered, placebo control, double blind, randomized clinical trial - HepVac-P2NAs
Hiasa Yoichi0 个研究点目标入组 140 人开始时间: 2022年3月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •Chronic hepatitis B patients who fulfill the inclusion criteria below
- •(1) 20-85 years old
- •(2) Positive fo HBsAg or HBV-DNA
- •(3) Taking nucleos(t)ide analogue
- •(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) Inappropriate to participate in this trial
研究者
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