Study to evaluate safety and efficacy of Lifeliver in acute or acute-on-chronic liver failure patients
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003748
- Lead Sponsor
- HLB CE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety : Incidence of transition of PERV (Porcine Endogenous Retrovirus) (for experimental group only);Efficacy : To campare of 30 days survival rate of LifeLiver treatment with best supportive care;Safety : Occurrence of clinical safety laboratory adverse events
- Secondary Outcome Measures
Name Time Method