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

HLB Cell Co., Ltd.

Status and phase: Unknown; Phase 2

Conditions: Acute-On-Chronic Liver Failure; Acute Liver Failure

Treatments: Combination Product: LifeLiver

Study type: Interventional

Funder types: Industry

Identifiers

NCT03882346

LC-BAL-18

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control Group

No Intervention group

Description:

Patients in Control Group will receive best supportive care for the disease.

Experimental Group

Experimental group

Description:

Patients in Experimental Group will receive LifeLiver treatment in addition to best supportive care for the disease.

Treatment:

Combination Product: LifeLiver