CABA artificial liver system for end-stage liver disease with inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 study evaluates the safety and efficacy of the novel artificial liver combination CABA (BS330 bilirubin adsorption with CA280 cytokine adsorption) plus plasma exchange in adults with end-stage liver disease. ESLD patients with acute decompensation or chronic liver failure are included, with specific liver- and coagulation-related criteria. The approach aims to temporarily replace liver function, remove toxins, modulate immune dysfunction, and support potential recovery or peri-transplant needs. The study is conducted at Tongji Hospital in Wuhan, led by Qin Ning. Outcomes of interest include liver function, inflammatory markers, and clinical status during treatment sessions and follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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:

1. ALB\<35 g/L; A / G \<1.0;
2. TBIL\> 120 μ mol / L;
3. ALT\> 1 × ULN and/or AST\>1 × ULN;
4. PTA \<60%
5. Ascites or hepatic encephalopathy or bleeding from esophageal varices;

B. Chronic liver failure:

1. The basis of chronic liver disease: decompensated cirrhosis;
2. Time of onset: unlimited;
3. Hepatic encephalopathy: with or without;
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5;
5. Jaundice\>171.1umol/L;

C. Chronic plus acute liver failure:

1. Chronic liver disease is based on: chronic hepatitis or decompensated cirrhosis;
2. Time of onset:\<4 weeks;
3. Hepatic encephalopathy: with or without;
4. Coagulation: PTA ≤ 40% or INR ≥ 1.5;
5. Jaundice: TBIL ≥ 171 μ Mol/L or daily increase ≥ 17.1 μ mol/L

   ③ Inflammation status: the following 4 items meet any 2 items
   1. PCT≥0.50 μ g/L
   2. CRP≥40 mg/L
   3. IL-6 \> 5 × ULN
   4. IL-8 \> 5 × ULN

      ④ Understand and voluntarily sign the informed consent form approved by the Ethics Committee.

      Exclusion Criteria:
      * 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.

Where it's running

• Tongji Hospital
  Wuhan, Hubei, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.