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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05392673
Enrollment
186
Registered
2022-05-26
Start date
2020-06-01
Completion date
2021-10-31
Last updated
2022-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic-on-acute Liver Failure

Brief 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.

Interventions

OTHERKM-8800 plasma exchange device (Kuraray, Tokyo, Japan)

Artificial liver scavenges inflammatory factors.

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants with survival without liver transplantation90 days
Number of Participants with death90 days
Number of Participants with Liver transplantation90 days

Secondary

MeasureTime frameDescription
Progress of biochemical indexes90 dayselevated bilirubin and transaminase

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026