Acute-On-Chronic Liver Failure, Hepatitis B
Conditions
Keywords
hepatitis b virus, acute-on-chronic liver failure, artificial liver
Brief summary
This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with Hepatitis b virus related acute-on-chronic liver failure.
Detailed description
Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.
Interventions
OTHERPlasma exchange
Patients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time.
OTHERRL-1 Novel Human-derived Bio-artificial Liver Treatment
Patients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time.
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year; 2. Age from 18 to 65 years old; 3. Serum total bilirubin level \> 10 times upper limit of normal; 4. Prothrombin time activity \< 40% and ≥30%； 5. Platelets \> 50\*10 E9/L.
Exclusion criteria
1. Other active liver diseases; 2. Hepatocellular carcinoma or other malignancy; 3. Pregnancy or lactation; 4. Human immunodeficiency virus infection or congenital immune deficiency diseases; 5. Severe diabetes, autoimmune diseases; 6. Other important organ dysfunctions; 7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome; 8. Patients can not follow-up; 9. Investigator considering inappropriate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 4 week | All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms | 4 week | All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up. |
| Blood cells | 4 week | Blood cells are observed in the follow-up. |
| Alanine transaminase | 4 week | Alanine transaminase is observed in the follow-up. |
| Survival rate | 4 week | Whether patients will survive after treatment is observed in the follow-up. |
| Serum creatinine | 4 week | is observed in the follow-up. |
| Prothrombin time | 4 week | Prothrombin time is observed in the follow-up. |
| Blood ammonia | 4 week | Blood ammonia is observed in the follow-up. |
| Total bilirubin | 4 week | Total bilirubin is observed in the follow-up. |
Countries
China
Contacts
Primary ContactWenxiong Xu, Doctor
Backup ContactLiang Peng, Doctor
Outcome results
None listed