ISRCTN96199656已完成未知
A double blind, placebo controlled study to evaluate the safety and immunogenicity of escalating doses of 10^8 colony forming units (CFU), 10^9 CFU and 10^10 CFU of M04NM11 in patients who have chronic hepatitis B infection
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 45
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
- 性别
- All
入选标准
- •1. Participating patients must be over 18 years of age, either sex
- •2. Have been hepatitis B surface antigen (HBsAg) positive for at least six months
- •3. A detailed medical history demonstrating stable alanine aminotransferase (ALT), prothrombin time (PT) and serum bilirubin and a liver biopsy in the previous 24 months
- •4. Patients will be stratified and recruited according to hepatitis B 'e' antigen (HBeAg) status and viral deoxyribonucleic acid (DNA) load
排除标准
- •1. Have any hypersensitivity to the investigational medicinal product (IMP)
- •2. Are hepatitis C virus (HCV) or hepatitis D virus (HDV) positive
- •3. Are receiving or have received medication for their hepatitis B in the previous 12 months
- •4. Have evidence of hepatic decompensation, cirrhosis or ALT greater than 5.1 x upper limit of normal (ULN), PT greater than 1.25 x ULN or total bilirubin greater than 1.5 x ULN
- •5. Immuno-suppression or close contact with immuno-suppressed people
研究者
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