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

May 24, 2022 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Changsha, China
        • Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: comprehensive medical treatment
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)
Artificial liver scavenges inflammatory factors.
Other Names:
  • EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan)
  • BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China)
  • The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology)
Experimental: PE(plasma exchange)
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)
Artificial liver scavenges inflammatory factors.
Other Names:
  • EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan)
  • BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China)
  • The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology)
Experimental: DPMAS+half-dose sequential PE
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)
Artificial liver scavenges inflammatory factors.
Other Names:
  • EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan)
  • BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China)
  • The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Wenting Peng, Xiangya Hospital of Central South University, Changsha, Hunan Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 24, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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