Hepatic dysfunction and hepatic failure
Conditions
Interventions
Group A:Plasma Exchange+Continuous Venous-venous Hemofiltration
Group B:Plasma Exchange+Continuous Venous-venous Hemofiltration+ELAD
Sponsors
Vital Therapies Inc
Eligibility
Sex/Gender
All
Age
15 Years to 66 Years
Inclusion criteria
Inclusion criteria: 1. Chinese citizen, male or female, age range 15-66 y (including 15y and 66y); can afford the expense of basic treatments except ELAD; 2. Acute, sub-acute, acute or chronic (i.e., chronic severe hepatitis) hepatic dysfunction and hepatic failure caused by various reasons; e.g., virus, alcohol, drug or inherited metabolic disease; 3. Obvious gastrointestinal and/or systemic toxic symptoms; 4. TBil>=5XULN, or the daily increase of total bilirubin > 1mg/dL(17.1umol/L; 5. Prothrombin time activity (PTA)> 10% and 50%; or INR> 1.6 and 4.0, or PT >=5 sec. and 20 sec. longer than control; 6. Without hepatoencephalopathy, or encephalopathy below Grade II (including Grade II); 7. Patient or its legal representative could understand and sign the informed consent form, could exchange information with the investigator, could understand and cooperate the implementation of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Primary or metastasis liver cancer; 2. Medical history of Definite decompensated cirrhosis. (have one of followings: PTA2*ULN; bleeding; hepatoencephalopathy; ascites) within one year before screening; 3. Slowly progressed hepatic cirrhosis and hepatic failure; 4. Existence of uncontrolled severe infection, such as septicemia, pneumonia (after appropriate treatment of antibiotics, X-ray shows no improvement), abdominal cavity infection (after appropriate treatment of antibiotics, still have signs of peritonitis or White Cells of ascites>0.1*10^9/L), and etc. 5. Shock; 6. Active gastrointestinal bleeding or obvious bleeding in other sites with poor effect of hemostatic treatment within three days; 7. Grade III and IV hepatoencephalopathy; 8. Platelet 1.5mg/dL; 10. Besides liver damage, there exists any other severe active physical or mental diseases that might affect the treatment, evaluation or compliance on the discretion of the investigator, including any uncontrolled clinically significant primary renal, cardiac, pulmonary, vascular, nervous, digestive, metabolic diseases (obvious hyperthyroidism, severe diabetes and adrenal gland disease)and immune deficiency or cancer; 11. Unable to cooperate in the trial or follow-up; 12. Highly allergic to heparin or protamine; 13. Planned to undergo liver transplantation or has undergone liver transplantation within 3 weeks before screening; 14. Pregnancy or lactation; 15. Other non-biological artificial liver and relevant blood purification treatment within 3 days before screening; 16. Still in or has participated in any trials of investigational drugs within 3 months before screening; 17. Unsuitable for the treatment according to other doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survial Time and Survival Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| PTA, MELD, CTP, APACHE, SOFA, Bilirubin, Albumin, PA, CHE, INR, APTT, FIB, ammonia, every symptoms, signs, etc.; | — |
Countries
China
Contacts
Public ContactZhongping Duan
Outcome results
None listed