Study to Evaluate Safety and Efficacy of LifeLiver in Acute or Acute-on-Chronic Liver Failure Patients
NCT03882346 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2020-04-28
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.
Conditions
- Acute Liver Failure
- Acute-On-Chronic Liver Failure
Interventions
- 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.
Sponsors & Collaborators
-
HLB Cell Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Dong Hyun Sinn, MD, Ph.D · Samsung Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-29
- Primary Completion
- 2022-03-31
- Completion
- 2022-06-30
Countries
- South Korea
Study Locations
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