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Evaluation of ZhJ-III hybrid bioartificial liver in the treatment of patients with liver failure: an early stage prospective randomized controlled trial

Evaluation of ZhJ-III hybrid bioartificial liver in the treatment of patients with liver failure: an early stage prospective randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016021
Enrollment
Unknown
Registered
2018-05-07
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-05-14

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

Conditions

Liver failure

Interventions

Treatment group:Standard of care plus ZhJ-III hybrid bioartificial liver
Control group:Standard of care plus DPMAS

Sponsors

Zhujiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~55 years old, all genders; 2. Early or middle stage of sub-acute and chronic on acute liver failure patients caused by HBV; 3. TBil =171umol/L or TBil daily increase more than 17.1 umol/L; 4. PTA between 20% to 50% or INR between 1.5 to 2.6; 5. Without hepatic encephalopathy or less than grade II (grade II included); 6. Patient who is able to understand and sign informed consent, communicate and cooperate with researchers to execute the study.

Exclusion criteria

Exclusion criteria: 1. Primary hepatic carcinoma or metastatic liver cancer; 2. Serious active hemorrhage or disseminated intravascular coagulation; 3. Highly allergic to plasma, heparin or protamine; 4. Circulatory failure; 5. MELD>30; 6. Any uncontrolled clinically significant primary cardiac, pulmonary, vascular, autoimmune diseases or severe diabetes; 7. Any other severe active physical or mental diseases that might affect the treatment, evaluation or compliance on the discretion of the investigator.

Design outcomes

Primary

MeasureTime frame
CLIF-SOFA;

Secondary

MeasureTime frame
Cure rate;CLIF-SOFA;Survival rate;Biochemical indicator;Coagulation function;Inflammatory factors;Endotoxin;

Countries

China

Contacts

Public ContactGAO YI

Zhujiang Hospital of Southern Medical University

gaoyi6146@163.com+86 020-61643207

Outcome results

None listed

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