NCT05392673

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (actual)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic-on-acute Liver Failure

Interventions

Type	Name	Description
OTHER	KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)	Artificial liver scavenges inflammatory factors.

Timeline

• Start date: 2020-06-01
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2022-05-26
• Last updated: 2022-05-26

Locations

1 site across 1 country: China