Clinical trial NCT05392673: Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure.
Official title: Comparative Analysis on Short-term Efficacies of Two Kinds of Artificai Liver Method in Treating Severe Hepatitis B.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic-on-acute Liver Failure
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with survival without liver transplantation
timeFrame: 90 days
measure: Number of Participants with death
timeFrame: 90 days
measure: Number of Participants with Liver transplantation
timeFrame: 90 days
Secondary outcomes:
measure: Progress of biochemical indexes
timeFrame: 90 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
Study officials:
affiliation: Xiangya Hospital of Central South University, Changsha, Hunan Province
name: Wenting Peng
role: PRINCIPAL_INVESTIGATOR
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