KCT0003748招募中未知
A Phase 2b study to evaluate safety and efficacy of Lifeliver(Bio Artificaial Liver) in acute or acute-on-chronic liver failure patients waiting emergent liver transplantation.
HLB CE0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 60(Year)（—）
- 性别
- All
入选标准
- •1. 18 to 60 years of age
- •2. Acute or acute-on-chronic liver failure patients who is waiting for liver transplantation (Korean Netmwork for Organ Sharing(KONOS) liver transplant emergency grade 2 or 3)
- •3. Hepatic encephalopathy grade II or above
- •4. INR (international normalized ratio) 2.0 or above
- •5. Serum ammonia 56 micromole/L or above
- •6. Total bilirubin 5mg/dL or above
- •7. Body weight 45kg or above
- •8. Patient who can not expect effective treatment or prolonged survival
- •9. Patient or patient's legal representative willing to cooperate and comply with the restrictions during the trial period
- •10. Patient or patient's legal representative willing to provide informed consent and commit to study procedures
排除标准
- •1. Patient who has contraindication to plasmapheresis
- •2. Severe hypotension (systolic blood pressure 80mmHg or less)
- •3. Platelet < 15,000/mm3
- •4. Contraindications to liver transplantation (sepsis, severe heart disease, uncontrollable hemorrhage, irreversible brain damage)
- •5. Cerebral hemorrhage
- •6. Positive HIV infection
- •7. Serious or life-threatening hemorrhage just before initiation of the study
- •8. Patients with high gastrointestinal bleeding tendency (a history or suspicion of gastrointestinal bleeding within last 3 months)
- •9. Hepatocellular carcinoma patient with 7 (or more) tumors or a 6cm (or larger) diameter single tumor
- •10. Pregnant or lactating women
- •11. Antibiotics (beta-lactam family) hypersensitive and streptomycin, amphotericin B sensitive patients
- •12. Patients with inappropriate condition to participate the study under investigator's judgement
- •13. Patients currently participating in other clinical trials
研究者
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