Clinical Observation of CABA System in the Treatment of End-stage Liver Disease With Inflammation

NCT05780190 | Unknown Phase 4

• 1 other identifier: CABA STUDY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. ESLD is an important cause of global incidence rate and mortality, which has a significant impact on the health care system. ESLD is associated with various types of immune dysfunction. The artificial liver support system (ALSS) is an extracorporeal support system that temporarily and partially replaces the partial function of the liver. Its treatment mechanism is to remove all kinds of harmful substances, supplement essential substances, improve the internal environment, create conditions for hepatocyte regeneration and liver function recovery, or use it as a symptomatic support treatment method during the perioperative period of liver transplantation. In this study, we plan to use BS330 for plasma bilirubin adsorption. On this basis, we will add a CA280 cytokine adsorption column to establish a new artificial liver combination model CABA for the immune inflammatory damage mechanism of liver failure.

Conditions

To Evaluate the Clinical Efficacy and Safety of the New ALSS

Outcome Measures

Primary Outcomes (1)

• non-transplantation mortality

  the 28-day and 90-day non-transplantation mortality

  1 year

Study Arms (2)

CABA group

EXPERIMENTAL

new artificial liver CABA system (BS330+CA280) combined with plasma exchange

Device: New artificial liver CABA system (BS330+CA280) +PE

control group

EXPERIMENTAL

BS330 combined with plasma exchange

Device: New artificial liver CABA system (BS330+CA280) +PE

Interventions

New artificial liver CABA system (BS330+CA280) +PE DEVICE

The new artificial liver CABA system (BS330+CA280) combioned plasma exchange in the treatment of end-stage liver disease with inflammatory status

Also known as: standard drug therapy

CABA group; control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ① Age 18-70;
• ② Patients with end-stage liver disease, including patients with acute decompensation of cirrhosis, chronic liver failure and patients with chronic and acute liver failure in Child-Pugh grade B-C;
• A. Acute decompensation of liver cirrhosis:
• ALB\<35 g/L; A / G \<1.0;
• TBIL\> 120 μ mol / L;
• ALT\> 1 × ULN and/or AST\>1 × ULN;
• PTA \<60%
• Ascites or hepatic encephalopathy or bleeding from esophageal varices;
• B. Chronic liver failure:
• The basis of chronic liver disease: decompensated cirrhosis;
• Time of onset: unlimited;
• Hepatic encephalopathy: with or without;
• Coagulation: PTA ≤ 40% or INR ≥ 1.5;
• Jaundice\>171.1umol/L;
• C. Chronic plus acute liver failure:

You may not qualify if:

• Patients with liver malignant tumor and other tumors;
• People with HIV infection or other immunodeficiency diseases;
• Pregnant or lactating women;
• Patients with autoimmune disease, unstable stage of infarction caused by cardio-cerebrovascular accident, history of organ transplantation and other organ dysfunction or failure; ⑤ Patients with other serious complications (such as active bleeding, diffuse intravascular coagulation); ⑥ Those who are unable to return to the hospital for further consultation and follow-up regularly according to the research plan;
• Those who fail to comply with the research arrangement and sign the informed consent form; ⑧ Other conditions judged by the researcher not suitable for the group.

Sponsors & Collaborators

• Qin Ning: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: CABA+PE+standard drug therapy and PP+PE+standard drug therapy

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: March 10, 2023
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)