To Evaluate the Clinical Efficacy and Safety of the New ALSSPhase 4NCT05780190
Clinical Observation of CABA System in the Treatment of End-stage Liver Disease With Inflammation
A Phase 4 study testing New artificial liver CABA system (BS330+CA280) +PE in people with To Evaluate the Clinical Efficacy and Safety of the New ALSS, run by Qin Ning at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- To Evaluate the Clinical Efficacy and Safety of the New ALSS
- What is being tested?
- New artificial liver CABA system (BS330+CA280) +PE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2023to 10 Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- 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;
Show all 26Show fewer
- PTA <60%
- Ascites or hepatic encephalopathy or bleeding from esophageal varices;
- 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;
- Chronic plus acute liver failure:
- Chronic liver disease is based on: chronic hepatitis or decompensated cirrhosis;
- Time of onset:<4 weeks;
- Hepatic encephalopathy: with or without;
- Coagulation: PTA ≤ 40% or INR ≥ 1.5;
- 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
- PCT≥0.50 μ g/L
- CRP≥40 mg/L
- IL-6 > 5 × ULN
- IL-8 > 5 × ULN
- ④ Understand and voluntarily sign the informed consent form approved by the Ethics Committee.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital
Wuhan, Hubei, 430030
Yang Zhongyuan, MD/PhD, 0086 2783662391, 1049446560@qq.com
About this study
Official title: Clinical Observation of New Artificial Liver CABA System (BS330+CA280) in the Treatment of End-stage Liver Disease With Inflammation
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.
Read the detailed description
End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that the liver function cannot meet the physiological needs of the human body. Its scope includes the end stage of various chronic liver diseases, including chronic plus acute liver failure (ACLF), acute decompensation of cirrhosis (ADC), chronic liver failure (CLF) and hepatocellular carcinoma. 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 symptoms of these immune dysfunction are called cirrhosis-related immune dysfunction (CAID), characterized by immune deficiency and systemic inflammation caused by the continuous and inappropriate activation of immune cells. In compensated cirrhosis, even without intestinal bacterial translocation, the damage-related molecular patterns (DAMPs) released by necrotic hepatocytes can activate the immune system and cause systemic inflammation. During the decompensation period, the bacterial products produced by intestinal bacterial translocation enhance immune activation and increase the expression of pro-inflammatory cytokines and immune cell activation antigens in the circulation. Cytokines are the key components of the immune system, with a variety of characteristics and biological functions. Systemic inflammation associated with CAID is associated with increased circulating levels of pro-inflammatory cytokines such as interleukin (IL) - 6. Studies have shown that there is a relationship between the severity of immune disorders and the prognosis of liver cirrhosis. The levels of IL-6, IL-10 and IL-17 are increased in liver cirrhosis.
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. Plasma bilirubin adsorption is the specific adsorption of bilirubin through anion resin adsorption column, which can effectively reduce the level of bilirubin and bile acid, thus improving the internal environment of the machine and helping the further repair of damaged liver cells. Cytokine adsorption is designed to reduce the level of cytokines represented by IL-6 through the cytokine adsorption column. In clinical practice, it is mainly used to reduce the level of circulating pro-inflammatory cytokines and early harmful effects in the first few hours and days of treatment of infectious shock, so as to improve the treatment effect of patients. 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. This treatment model can not only absorb bilirubin, but also effectively remove more inflammatory factors. In this study, patients with end-stage liver disease and inflammatory status will be selected as the observation object, and the new CABA combination will be used for treatment, and the clinical effectiveness and safety of this treatment mode will be evaluated, aiming to provide evidence-based medical evidence for the clinical application and promotion of this treatment mode.
- Being tested
- New artificial liver CABA system (BS330+CA280) +PE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New artificial liver CABA system (BS330+CA280) +PEDevice
Also called standard drug therapy
The new artificial liver CABA system (BS330+CA280) combioned plasma exchange in the treatment of end-stage liver disease with inflammatory status
| Study group | Role | What they receive |
|---|---|---|
| CABA group | Experimental | new artificial liver CABA system (BS330+CA280) combined with plasma exchange Receives: Device: New artificial liver CABA system (BS330+CA280) +PE |
| control group | Experimental | BS330 combined with plasma exchange Receives: Device: New artificial liver CABA system (BS330+CA280) +PE |
What is being measured
The primary outcome is the main question the study is designed to answer.
non-transplantation mortality
the 28-day and 90-day non-transplantation mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start10 Mar 2023
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Evaluate the Clinical Efficacy and Safety of the New ALSSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CABA+PE+standard drug therapy and PP+PE+standard drug therapy
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qin Ning
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780190
- Sponsor's protocol ID
- CABA STUDY
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of New Artificial Liver CABA System (BS330+CA280) in the Treatment of End-stage Liver Disease With Inflammation
- ClinicalTrials.gov ID
- NCT05780190
- Acronym / sponsor ID
- CABA STUDY
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qin NingUniversity, hospital or other
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
End-stage liver disease (ESLD) refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that the liver function cannot meet the physiological needs of the human body. Its scope includes the end stage of various chronic liver diseases, including chronic plus acute liver failure (ACLF), acute decompensation of cirrhosis (ADC), chronic liver failure (CLF) and hepatocellular carcinoma. 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 symptoms of these immune dysfunction are called cirrhosis-related immune dysfunction (CAID), characterized by immune deficiency and systemic inflammation caused by the continuous and inappropriate activation of immune cells. In compensated cirrhosis, even without intestinal bacterial translocation, the damage-related molecular patterns (DAMPs) released by necrotic hepatocytes can activate the immune system and cause systemic inflammation. During the decompensation period, the bacterial products produced by intestinal bacterial translocation enhance immune activation and increase the expression of pro-inflammatory cytokines and immune cell activation antigens in the circulation. Cytokines are the key components of the immune system, with a variety of characteristics and biological functions. Systemic inflammation associated with CAID is associated with increased circulating levels of pro-inflammatory cytokines such as interleukin (IL) - 6. Studies have shown that there is a relationship between the severity of immune disorders and the prognosis of liver cirrhosis. The levels of IL-6, IL-10 and IL-17 are increased in liver cirrhosis.
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. Plasma bilirubin adsorption is the specific adsorption of bilirubin through anion resin adsorption column, which can effectively reduce the level of bilirubin and bile acid, thus improving the internal environment of the machine and helping the further repair of damaged liver cells. Cytokine adsorption is designed to reduce the level of cytokines represented by IL-6 through the cytokine adsorption column. In clinical practice, it is mainly used to reduce the level of circulating pro-inflammatory cytokines and early harmful effects in the first few hours and days of treatment of infectious shock, so as to improve the treatment effect of patients. 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. This treatment model can not only absorb bilirubin, but also effectively remove more inflammatory factors. In this study, patients with end-stage liver disease and inflammatory status will be selected as the observation object, and the new CABA combination will be used for treatment, and the clinical effectiveness and safety of this treatment mode will be evaluated, aiming to provide evidence-based medical evidence for the clinical application and promotion of this treatment mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- CABA+PE+standard drug therapy and PP+PE+standard drug therapy
| Arm | Type | Receives |
|---|---|---|
| CABA group | Experimental | Device: New artificial liver CABA system (BS330+CA280) +PEnew artificial liver CABA system (BS330+CA280) combined with plasma exchange |
| control group | Experimental | Device: New artificial liver CABA system (BS330+CA280) +PEBS330 combined with plasma exchange |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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;
- Acute decompensation of liver cirrhosis:
- ALB<35 g/L; A / G <1.0;
- TBIL> 120 μ mol / L;
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New artificial liver CABA system (BS330+CA280) +PEAlso: standard drug therapyThe new artificial liver CABA system (BS330+CA280) combioned plasma exchange in the treatment of end-stage liver disease with inflammatory status | Device | CABA group, control group |
Primary outcome
non-transplantation mortality
Time frame: 1 year
the 28-day and 90-day non-transplantation mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing New artificial liver CABA system (BS330+CA280) +PE in people with To Evaluate the Clinical Efficacy and Safety of the New ALSS, run by Qin Ning at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
non-transplantation mortality (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.