Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
A Phase 2b Study to Evaluate Safety and Efficacy of LifeLiver (Bio Artificial Liver) in Acute or Acute-on-Chronic Liver Failure Patients Waiting Emergent Liver Transplantation
1 other identifier
interventional
40
1 country
1
Brief Summary
This is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of LifeLiver (an Extracorporeal Bio Artificial Liver). The study will recruit approximately 40 acute or acute-on-chronic liver failure patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2019
CompletedFirst Posted
Study publicly available on registry
March 20, 2019
CompletedStudy Start
First participant enrolled
March 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedApril 28, 2020
April 1, 2020
2.9 years
March 13, 2019
April 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Survival rate for 30 days
To compare survival rate of LifeLiver treatment with best supportive care
up to 30 days
Occurrence of clinical safety laboratory adverse events (AEs)
To compare occurrence of clinical safety laboratory adverse events between Experimental group and Control group assessed according to NCI-CTCAE v5.0
up to approximately 12 months
Incidence of transition of PERV (Porcine Endogenous Retrovirus) (for experimental group only)
Number of reported PERV transition defined as viral detection in subject's blood by PCR (Polymerase Chain Reaction) test.
up to approximately 12 months
Secondary Outcomes (9)
Survival rate for 14 days
up to 14 days
Median value of duration of survival
up to approximately 12 months
Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37
up to 30 days
Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37
up to 30 days
Comparison of MELD score
up to approximately 12hours after completion of LifeLiver treatment
- +4 more secondary outcomes
Study Arms (2)
Control Group
NO INTERVENTIONPatients in Control Group will receive best supportive care for the disease.
Experimental Group
EXPERIMENTALPatients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease.
Interventions
LifeLiver is an extracorporeal bioartificial liver (BAL) system. The system has shown remarkable detoxification capacity and sustained hepatic functions and also provides a bridge to transplant for patients who are unable to receive timely liver transplantation.
Eligibility Criteria
You may qualify if:
- to 60 years of age
- Acute or acute-on-chronic liver failure patients who is waiting for liver transplantation (KONOS liver transplant emergency grade 2 or 3)
- Hepatic encephalopathy grade II or above
- The following laboratory values must be documented within the screening period:
- INR (international normalized ratio) 2.0 or above
- Serum ammonia 56 micromole/L or above
- Total bilirubin 5mg/dL or above
- Body weight 45kg or above
- Patient who can not expect effective treatment or prolonged survival
- Patient or patient's legal representative willing to provide informed consent and commit to study procedures
You may not qualify if:
- Patient who has contraindication to plasmapheresis
- Severe hypotension (systolic blood pressure 80mmHg or less)
- Platelet \< 15,000/mm3
- Contraindications to liver transplantation (sepsis, severe heart disease, uncontrollable hemorrhage, irreversible brain damage)
- Cerebral hemorrhage
- Positive HIV infection
- Serious or life-threatening hemorrhage just before initiation of the study
- Patients with high gastrointestinal bleeding tendency (a history or suspicion of gastrointestinal bleeding within last 3 months)
- Hepatocellular carcinoma patient with 7 (or more) tumors or a 6cm (or larger) diameter single tumor
- Pregnant or lactating women
- Antibiotics (beta-lactam family) hypersensitive and streptomycin, amphotericin B sensitive patients
- Patients with inappropriate condition to participate the study under investigator's judgement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 06351, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dong Hyun Sinn, MD, Ph.D
Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2019
First Posted
March 20, 2019
Study Start
March 29, 2019
Primary Completion
March 1, 2022
Study Completion
June 1, 2022
Last Updated
April 28, 2020
Record last verified: 2020-04