Acute Liver FailurePhase 2NCT03882346
Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
A Phase 2 study testing LifeLiver in people with Acute Liver Failure and Acute-On-Chronic Liver Failure, run by HLB Cell Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Liver Failure, Acute-On-Chronic Liver Failure
- What is being tested?
- LifeLiver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Mar 2019to Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Sanghoon Lee, MD, Ph.D, +82-2-3410-0928, sanghoone.lee@samsung.com
About this study
Official title: 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
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.
Read the 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:
- 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
- Being tested
- LifeLiver
- Keywords
- Acute Liver Failure, Acute-On-Chronic Liver Failure, Artificial Liver, Liver Transplantation
- Medical subject headings
- Liver Failure, Acute, Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeLiverCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Patients in Control Group will receive best supportive care for the disease. |
| Experimental Group | Experimental | Patients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease. Receives: Combination Product: LifeLiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate for 30 days
To compare survival rate of LifeLiver treatment with best supportive care
Measured: 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
Measured: 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.
Measured: up to approximately 12 months
Secondary outcomes (9)
Survival rate for 14 days
To compare survival rate of LiveLiver treatment with best supportive care
Measured: up to 14 days
Median value of duration of survival
To compare Median value of duration of survival between experimental group and control group
Measured: up to approximately 12 months
Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37
To compare Kaplan-Meier estimate of both (experimental and control) groups at 14 days and 30 days
Measured: up to 30 days
Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37
To compare Kaplan-Meier estimate of both groups at 14 days and 30 days
Measured: up to 30 days
Comparison of MELD score
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)
Measured: up to approximately 12hours after completion of LifeLiver treatment
Comparison of subject's neurological status - hepatic encephalopathy grade
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)
Measured: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's neurological status - Glasgow Coma Scale
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)
Measured: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of blood ammonia
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
Measured: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of inflammatory cytokines
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)
Measured: up to approximately 12 hours after completion of LifeLiver treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start29 Mar 2019
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel, open label study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HLB Cell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Hyun Sinn, MD, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882346
- Sponsor's protocol ID
- LC-BAL-18
- Status last verified
- Apr 2020
- First submitted
- 13 Mar 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03882346
- Acronym / sponsor ID
- LC-BAL-18
- Keywords
- Acute Liver Failure, Acute-On-Chronic Liver Failure, Artificial Liver, Liver Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- HLB Cell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel, open label study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Patients in Control Group will receive best supportive care for the disease. |
| Experimental Group | Experimental | Combination Product: LifeLiverPatients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- Patient who can not expect effective treatment or prolonged survival
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LifeLiverLifeLiver 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. | Combination product | Experimental Group |
Primary outcome
Survival rate for 30 days
Time frame: up to 30 days
To compare survival rate of LifeLiver treatment with best supportive care
Occurrence of clinical safety laboratory adverse events (AEs)
Time frame: up to approximately 12 months
To compare occurrence of clinical safety laboratory adverse events between Experimental group and Control group assessed according to NCI-CTCAE v5.0
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.
9 secondary outcomes
Survival rate for 14 days
Time frame: up to 14 days
Median value of duration of survival
Time frame: up to approximately 12 months
Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37
Time frame: up to 30 days
Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37
Time frame: up to 30 days
Comparison of MELD score
Time frame: up to approximately 12hours after completion of LifeLiver treatment
Comparison of subject's neurological status - hepatic encephalopathy grade
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's neurological status - Glasgow Coma Scale
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of blood ammonia
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Comparison of subject's value of inflammatory cytokines
Time frame: up to approximately 12 hours after completion of LifeLiver treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Hyun Sinn, MD, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LifeLiver in people with Acute Liver Failure and Acute-On-Chronic Liver Failure, run by HLB Cell Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Younyoung Hwang (+82-2-2627-6773, yy.hwang@hlb-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate for 30 days (time frame: up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.