KCT0003748
Recruiting
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 sites40 target enrollmentTBD
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- HLB CE
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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