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To investigate the safety and efficacy of HepAssis2® bioartificial liver in patients with liver failure: a prospective, randomized controlled clinical trial

To investigate the safety and efficacy of HepAssis2® bioartificial liver in patients with liver failure: a prospective, randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075781
Enrollment
Unknown
Registered
2023-09-15
Start date
2016-10-19
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver failure

Interventions

Experimental group:All the enrolled subjects received a total of 5 treatments. In the experimental group, the examination indexes and treatment conditions were evaluated after 3 times of bioartificial
Control group:The control group completed 3 times of physical artificial liver treatment within 1 week and evaluated the examination indexes and treatment status. If the treatment was effective, the t

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The patients or their legal representatives could understand and voluntarily sign the informed consent, communicate with the researchers, understand and cooperate with the implementation of the plan. (2) Age of 18-65 years old, regardless of gender. (3) patients with early and middle stage acute, subacute, acute-on-chronic, and subacute chronic liver failure caused by various reasons (progressive deepening of jaundice (serum total bilirubin > 171µmol/L or a daily increase in total bilirubin =17.1µmol/L; Bleeding tendency, PTA= 40%) . (4) patients with advanced liver failure waiting for donor before liver transplantation, rejection after liver transplantation, and non-functional phase of transplanted liver. (5) The clinical diagnosis did not meet the criteria of severe hepatitis or liver failure, but the comprehensive judgment showed a significant tendency to develop into liver failure (serum total bilirubin > 85.5µmol/L and serum total bilirubin increased =17.1µmol/L daily; Significant bleeding tendency, PTA= 50%). (6) hyperbilirubinemia caused by various reasons (serum total bilirubin > 171µmol/L) and ineffective medical treatment.

Exclusion criteria

Exclusion criteria: (1) Patients with severe active bleeding or disseminated intravascular coagulation. (2) unstable cardiac or cerebral infarction; (3) extrahepatic malignant tumors that are difficult to cure radically. (4) patients with severe hypotension or systemic circulatory failure such as shock. (5) In the late stage of the disease, there were irreversible respiratory failure, severe cerebral edema with cerebral hernia and other endangered symptoms. (6) severe systemic infection, including pulmonary infection, sepsis, abdominal infection, intracranial infection, and active tuberculosis. (7) acquired human immunodeficiency syndrome virus (HIV) infection. (8) Severe allergies to blood products or drugs used in the treatment, such as plasma, heparin or protamine. (9) pregnant women. (10) Psychiatric patients with a history of mental illness or under treatment, poor compliance, inability to cooperate with research or follow up, and other conditions deemed unsuitable for treatment by doctors.

Design outcomes

Primary

MeasureTime frame
Liver function and kidney function;Coagulation function;Survival time;

Secondary

MeasureTime frame
MELD score;Child Pugh rating;

Countries

China

Contacts

Public ContactYe qifa

Zhongnan Hospital of Wuhan University

yqf_china@163.com+86 138 7598 7051

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026