- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882346
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Patient should have acute or acute-on-chronic liver failure and be registered in KONOS (Korean Network for Organ Sharing) system as a candidate of liver transplantation. Patients who meet the eligibility criteria will be assigned to control group or experimental group. Experimental group patients will receive LifeLiver treatment in addition to the best supportive care for the disease.
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:
- To compare a median value of 2 week-survival rate and duration of survival between both study groups
- Survival analysis respect to each group of patients divided according to the KONOS status
- 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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Younyoung Hwang
- Phone Number: +82-2-2627-6773
- Email: yy.hwang@hlb-bio.com
Study Contact Backup
- Name: Eunyoung Kim
- Phone Number: +82-2-2627-6791
- Email: ey.kim@hlb-bio.com
Study Locations
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-
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Seoul, Korea, Republic of, 06351
- Recruiting
- Samsung Medical Center
-
Contact:
- Sanghoon Lee, MD, Ph.D
- Phone Number: +82-2-3410-0928
- Email: sanghoone.lee@samsung.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
Patients in Control Group will receive best supportive care for the disease.
|
|
Experimental: Experimental Group
Patients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate for 30 days
Time Frame: up to 30 days
|
To compare survival rate of LifeLiver treatment with best supportive care
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up to 30 days
|
Occurrence of clinical safety laboratory adverse events (AEs)
Time Frame: up to approximately 12 months
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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
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Incidence of transition of PERV (Porcine Endogenous Retrovirus) (for experimental group only)
Time Frame: up to approximately 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival rate for 14 days
Time Frame: up to 14 days
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To compare survival rate of LiveLiver treatment with best supportive care
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up to 14 days
|
Median value of duration of survival
Time Frame: up to approximately 12 months
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To compare Median value of duration of survival between experimental group and control group
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up to approximately 12 months
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Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37
Time Frame: up to 30 days
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To compare Kaplan-Meier estimate of both (experimental and control) groups at 14 days and 30 days
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up to 30 days
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Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37
Time Frame: up to 30 days
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To compare Kaplan-Meier estimate of both groups at 14 days and 30 days
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up to 30 days
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Comparison of MELD score
Time Frame: up to approximately 12hours after completion of LifeLiver treatment
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Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's MELD score (range of minimum 6 to maximum 40)
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up to approximately 12hours after completion of LifeLiver treatment
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Comparison of subject's neurological status - hepatic encephalopathy grade
Time Frame: up to approximately 12 hours after completion of LifeLiver treatment
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Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's hepatic encephalopathy grade (range of minimum 1 to maximum 4)
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up to approximately 12 hours after completion of LifeLiver treatment
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Comparison of subject's neurological status - Glasgow Coma Scale
Time Frame: up to approximately 12 hours after completion of LifeLiver treatment
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Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's Glasgow Coma Scale (range of minimum 3 to maximum 15)
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up to approximately 12 hours after completion of LifeLiver treatment
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Comparison of subject's value of blood ammonia
Time Frame: up to approximately 12 hours after completion of LifeLiver treatment
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Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of blood ammonia
|
up to approximately 12 hours after completion of LifeLiver treatment
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Comparison of subject's value of inflammatory cytokines
Time Frame: up to approximately 12 hours after completion of LifeLiver treatment
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Intra-group comparison (between pre and post 12 hours of LifeLiver treatment) and Inter-group comparison (between both groups) of subject's value of inflammatory cytokines (TNF-α, Interleukin-6, Interleukin-10)
|
up to approximately 12 hours after completion of LifeLiver treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dong Hyun Sinn, MD, Ph.D, Samsung Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC-BAL-18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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