Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
NCT ID: NCT03882346
Last Updated: 2020-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2019-03-29
2022-06-30
Brief Summary
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Detailed Description
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Primary Objective:
1\. To evaluate the efficacy of LifeLiver in terms of a comparison of 30 day-survival rate between control group and experimental group. (after patient's KONOS (Korean Network for Organ Sharing) registration date)
Secondary Objective:
1. To compare a median value of 2 week-survival rate and duration of survival between both study groups
2. Survival analysis respect to each group of patients divided according to the KONOS status
3. To investigate safety and change of overall efficacy indicators in terms of Glasgow Coma Scale, West Heaven Criteria for hepatic encephalopathy, MELD (Model for End-stage Liver Disease) score, blood ammonia, inflammatory cytokine
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
Patients in Control Group will receive best supportive care for the disease.
No interventions assigned to this group
Experimental Group
Patients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease.
LifeLiver
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.
Interventions
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LifeLiver
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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HLB Cell Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Dong Hyun Sinn, MD, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LC-BAL-18
Identifier Type: -
Identifier Source: org_study_id
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