MiroliverELAP® for the Treatment of Acute Liver Failure: a Phase 1 Trial

Open to people ages 18-80

1. 18 years to 80 years old at the time of signing the informed consent
2. Subject must:
   1. be deemed competent to consent by an independent qualified practitioner, or
   2. have consent given by a Legally Authorized Representative
3. Be diagnosed with acute liver failure as defined as:
   1. INR ≥ 2.5, and
   2. Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
   3. Less than 4 weeks (28 days) of disease duration
4. Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.

1. Underlying chronic liver disease, including:
   1. Acute-on-chronic liver disease
   2. Acute alcoholic-associated hepatitis
   3. Cirrhosis
2. Grade IV West Haven Encephalopathy Criteria
3. Previous liver transplant
4. Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
5. 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 0.3 mcg/kg/min.
6. Liver injury due to trauma
7. Any current liver cancer
8. Currently on medications with a narrow therapeutic index
9. Platelet count < 40,000 μL
10. If the subject is intubated and has an acute lung injury
11. Experiencing a bleeding event, defined as:
    1. Active gastrointestinal or other overt bleeding event, or
    2. Hemoglobin drop > 3g/dL within the past 24 hours, or
    3. Received ≥ 3 units of red blood cell transfusion within the past 24 hours
12. Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
13. Refusal to receive blood products