Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure.

Study Overview
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Brief Summary
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This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254 patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya Hospital, Central South University (Changsha, China). 186 patients who met the enrollment criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65 years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency virus(HIV) infection or other immunocompromised states; (5) complicated with underlying diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three groups whose age, sex ratio, complication, and liver function were comparable: comprehensive medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS + PE group). As a result, 62 subjects per group were recruited into the study. This study was approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South University with informed content obtained from all participants (No. 202201022). The study protocol followed the principles of the Helsinki Declaration strictly. All the 186 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment.

Official Title
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Comparative Analysis on Short-term Efficacies of Two Kinds of Artificai Liver Method in Treating Severe Hepatitis B.

Conditions
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Chronic-on-acute Liver Failure

Intervention / Treatment
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* Other: KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18-65 years old patients with ACLF caused by HBV infection meeting the diagnostic criteria for ACLF by the Asian Pacific Association for the Study of Liver. Exclusion Criteria: pregnancy or lactation previous liver transplantation hepatocellular carcinoma or other malignancy human immunodeficiency virus(HIV) infection or other immunocompromised state complicated with underlying diseases such as severe heart, respiratory, and blood system diseases

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: comprehensive medical treatment<br>All the 62 patients enrolled received comprehensive medical treatment after admission to the hospital, including anti-viral treatment, general supportive treatment, supplementation of blood products, such as albumin and plasma, and symptomatic treatment. | Other: KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)<br>* Artificial liver scavenges inflammatory factors.<br>* Other names: The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology);|
| Experimental: PE(plasma exchange)<br>In addition to comprehensive medical treatment, the PE groups were treated with PE or PE plus half-dose sequential PE. In the current study, PE was carried out using the KM-8800 plasma exchange device (Kuraray, Tokyo, Japan). The device was pre-flushed with 2000 mL of normal saline and 20 U/mL heparin dilution. And the blood pump speed was 100 to 120 mL/min and the plasma exchange speed was 25 to 30 mL/min. Before PE, calcium gluconate and diphenhydramine were routinely administrated to prevent an allergic reaction. For each time of plasma exchange,2800 mL fresh frozen plasma was administrated. | Other: KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)<br>* Artificial liver scavenges inflammatory factors.<br>* Other names: The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology);|
| Experimental: DPMAS+half-dose sequential PE<br>DPMAS with half-dose sequential PE was applied using the EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan), BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China), and the neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology). After the bilirubin adsorption and hemoperfusion treatment, sequential half-dose PE treatment begins. 1400 mL plasma replacement was conducted each time. | Other: KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)<br>* Artificial liver scavenges inflammatory factors.<br>* Other names: The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with survival without liver transplantation |  | 90 days | 
| Number of Participants with death |  | 90 days | 
| Number of Participants with Liver transplantation |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress of biochemical indexes | elevated bilirubin and transaminase | 90 days |