StudyFinder
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
RECRUITING
18 years to 80 years old
Inclusion Criteria:
• 18 years to 80 years old at the time of signing the informed consent
• Subject must:
• be deemed competent to consent by an independent qualified practitioner, or
• have consent given by a Legally Authorized Representative
• Subject should be in the intensive care unit
• Be diagnosed with 4.1. Acute Liver Failure defined as:
• INR ≥ 2.0, and
• Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
• Less than 4 weeks (28 days) of disease duration 4.2. Severe Acute Alcohol-Associated Hepatitis as defined as:
• Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
• Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
• INR ≥ 2.0, and
• No overt evidence of cirrhosis 4.3. Acute on Chronic Liver Failure:
• Hepatic Encephalopathy Grade I-III (West Haven Criteria), and
• Model for End-Stage Liver Disease (MELD) Score ≥ 20, and
• INR ≥ 2.0, 5\. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions. Exclusion Criteria
• Grade IV West Haven Encephalopathy Criteria
• Previous liver transplant
• Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
• Uncontrolled documented infection, hypotension, or refractory shock. This is defined as a need for a single vasopressor, or combination of vasopressors, that exceed a norepinephrine equivalent of 0.5 mcg/kg/min.
• Liver injury due to trauma
• Any current liver cancer
• Currently on medications with a narrow therapeutic index
• Platelet count \< 40,000 μL
• If the subject is intubated and has an acute lung injury
• Experiencing a bleeding event, defined as:
• Active gastrointestinal or other overt bleeding event, or
• Hemoglobin drop \> 3g/dL within the past 24 hours, or
• Received ≥ 3 units of red blood cell transfusion within the past 24 hours
• Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
• Refusal to receive blood products
COMBINATION_PRODUCT: miroliverELAP treatment
Acute Liver Failure, Acute Liver Injury, Drug Induced, Acute on Chronic Liver Failure (ACLF), Acute Alcoholic Hepatitis
Acute liver failure, Extracorporeal liver assist, Bioengineered liver
Joshua Carlson - jcarlson@miromatrix.com
PHASE1
NCT06285253