JPRN-jRCTs061200009招募中1 期
Phase I/II clinical trial of retreament by therapeutic vaccine containing HBsAg and HBcAg against HBV carrier - HepBVac-J1-2
Hiasa Yoichi0 个研究点目标入组 70 人开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
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
- •HBV asymptomatic carrier or chronic hepatitis B patients under nucleotide analogue treatment those who previously perticipated in phase I/II clinical trial of therapeutic vaccine
- •(1) Positive for HBsAg or HBV-DNA with previous history of perticipation of phase I/II clinical trial of NASVAC
- •(2) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- •(3) No evidence of organ dysfunction
- •Liver: Child-Pugh Score under 9
- •Kidney: eGFR more than 30ml/min
- •Heart: No abnormality in ECG
- •Lung: SpO2 more than 90% in room air
排除标准
- •(1) Allergic history against 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, interferons prior 90 days
- •(8) Inappropriate to participate in this trial
研究者
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