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The ELAD bio-artificial liver improved non-transplatation survival rate in patients with liver failure

The ELAD bio-artificial liver improved non-transplatation survival rate in patients with liver failure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004117
Enrollment
Unknown
Registered
2013-11-17
Start date
2006-03-02
Completion date
Unknown
Last updated
2017-04-18

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:ELAD treatment
control group:standard treatment

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 16~65 years old (16 years old and 65 years old included), all genders, ability to afford standard diagnosis and treatment cost; 2. Acute, sub-acute, chronic on acute (chronically severe hepatitis) liver dysfunction and failure caused by various reasons, such as viruses, alcohol, drug-induced, inborn metabolism etc.; 3. TBil>=5×ULN or TBil daily increase more than 1mg/dL (17.1umol/L); 4. PTA 20% to 50% or INR 1.6 to 4.0 or PT 5 seconds to 20 seconds; 5. Without hepatic encephalopathy or less than grade II (grade II included); 6. without or small to medium amount ascites; 7. Patient or his/her statutory agent is able to understand and sign informed consent, communicate and cooperate with researchers to execute the study.

Exclusion criteria

Exclusion criteria: Primary hepatic carcinoma or metastatic liver cancer. 1. Occurrence of decompensation of liver cirrhosis within one year (including one of the following items PTA2×ULN, bleeding, hepatic encephalopathy, ascites); 2. Slow progression of liver failure with liver cirrhosis; 3. Serious infection without control, such as sepsis, uncontrolled pneumonia (no improvement of X ray after proper antibiotic therapy); uncontrolled abdominal infection (peritonitis symptom or ascites WBC>0.1×10^9/L after antibiotic therapy ) etc.

Design outcomes

Primary

MeasureTime frame
survival rate;

Secondary

MeasureTime frame
Total bilirubin;

Countries

China

Contacts

Public ContactZhongping Duan

Beijing Youan Hospital, Capital Medical University

duan2517@163.com+86 13366425670

Outcome results

None listed

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