RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure

Conditions
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Hepatitis B, Acute-On-Chronic Liver Failure

Intervention / Treatment
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* Other: Plasma exchange
* Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year; Age from 18 to 65 years old; Serum total bilirubin level > 10 times upper limit of normal; Prothrombin time activity < 40% and ≥30%； Platelets > 50*10 E9/L. Exclusion Criteria: Other active liver diseases; Hepatocellular carcinoma or other malignancy; Pregnancy or lactation; Human immunodeficiency virus infection or congenital immune deficiency diseases; Severe diabetes, autoimmune diseases; Other important organ dysfunctions; Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome; Patients can not follow-up; Investigator considering inappropriate.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plasma exchange group<br>10 patients will receive conventional treatment plus plasma exchange | Other: Plasma exchange<br>* 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.<br>|
| Experimental: RL-1 Novel Human-derived Bio-artificial Liver treatment group<br>10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment | Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate | Whether patients will survive after treatment is observed in the follow-up. | 4 week | 
| Symptoms | All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up. | 4 week | 
| Blood cells | Blood cells are observed in the follow-up. | 4 week | 
| Alanine transaminase | Alanine transaminase is observed in the follow-up. | 4 week | 
| Total bilirubin | Total bilirubin is observed in the follow-up. | 4 week | 
| Serum creatinine | is observed in the follow-up. | 4 week | 
| Prothrombin time | Prothrombin time is observed in the follow-up. | 4 week | 
| Blood ammonia | Blood ammonia is observed in the follow-up. | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatitis b virus, acute-on-chronic liver failure, artificial liver