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Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882346
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
LIFELIVER

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.

Condition or disease Intervention/treatment Phase
Acute Liver Failure Acute-On-Chronic Liver Failure Combination Product: LifeLiver Phase 2

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:

  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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel, open label study
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 29, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


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.
Combination Product: 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.




Primary Outcome Measures :
  1. Survival rate for 30 days [ Time Frame: up to 30 days ]
    To compare survival rate of LifeLiver treatment with best supportive care

  2. 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

  3. 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.


Secondary Outcome Measures :
  1. Survival rate for 14 days [ Time Frame: up to 14 days ]
    To compare survival rate of LiveLiver treatment with best supportive care

  2. Median value of duration of survival [ Time Frame: up to approximately 12 months ]
    To compare Median value of duration of survival between experimental group and control group

  3. Kaplan-Meier estimate of subjects with MELD (Modell for End-stage Liver Disease) score >37 [ Time Frame: up to 30 days ]
    To compare Kaplan-Meier estimate of both (experimental and control) groups at 14 days and 30 days

  4. Kaplan-Meier estimate of subjects with 31≤ MELD score ≤37 [ Time Frame: up to 30 days ]
    To compare Kaplan-Meier estimate of both groups at 14 days and 30 days

  5. Comparison of MELD score [ Time Frame: up to approximately 12hours after completion of LifeLiver treatment ]
    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)

  6. Comparison of subject's neurological status - hepatic encephalopathy grade [ Time Frame: up to approximately 12 hours after completion of LifeLiver treatment ]
    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)

  7. Comparison of subject's neurological status - Glasgow Coma Scale [ Time Frame: up to approximately 12 hours after completion of LifeLiver treatment ]
    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)

  8. Comparison of subject's value of blood ammonia [ Time Frame: up to approximately 12 hours after completion of LifeLiver treatment ]
    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

  9. Comparison of subject's value of inflammatory cytokines [ Time Frame: up to approximately 12 hours after completion of LifeLiver treatment ]
    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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882346


Contacts
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Contact: Younyoung Hwang +82-70-4652-6677 yy.hwang@hlb-bio.com
Contact: Eunyoung Kim +82-70-4652-0213 ey.kim@hlb-bio.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Sanghoon Lee, MD, Ph.D    +82-2-3410-0928    sanghoone.lee@samsung.com   
Sponsors and Collaborators
LIFELIVER
Investigators
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Principal Investigator: Sukkoo Lee, MD, Ph.D Samsung Medical Center

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Responsible Party: LIFELIVER
ClinicalTrials.gov Identifier: NCT03882346    
Other Study ID Numbers: LC-BAL-18
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LIFELIVER:
Acute Liver Failure
Acute-On-Chronic Liver Failure
Artificial Liver
Liver Transplantation
Additional relevant MeSH terms:
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Liver Failure
Hepatic Insufficiency
End Stage Liver Disease
Acute-On-Chronic Liver Failure
Liver Failure, Acute
Liver Diseases
Digestive System Diseases
Liver Extracts
Hematinics