miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial

Launched by MIROMATRIX MEDICAL INC. · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial, called MiroliverELAP®, is studying a new treatment for people with acute liver failure, which is a serious condition where the liver stops working properly. The treatment involves a special device that acts like an external liver, supporting the body's own liver for up to 48 hours. This time can help the liver recover or determine if a liver transplant is needed. The trial is currently looking for participants aged 18 to 80 who have been diagnosed with acute liver failure but do not have chronic liver disease or other serious health issues.

To take part in the trial, individuals must be able to consent to participate, either on their own or through a representative if they're unable to. Participants will receive the experimental treatment and will be closely monitored for safety. It's important to note that those with ongoing liver issues, severe infections, recent liver transplants, or certain other health conditions may not be eligible. This trial aims to find out if miroliverELAP® is a safe option for treating this critical condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years to 80 years old at the time of signing the informed consent
• 2. Subject must:
• • a. be deemed competent to consent by an independent qualified practitioner, or b. have consent given by a Legally Authorized Representative
• 3. Be diagnosed with Acute Liver Failure or Severe Acute Alcohol-Associated Hepatitis as defined as:
• • 1. INR ≥ 2.0, and
• • 2. Hepatic Encephalopathy Grade II-III (West Haven Criteria), and
• • 3. Less than 4 weeks (28 days) of disease duration
• 4. If the etiology is alcohol-associated hepatitis, the following must be true:
• • i. This enrollment hospitalization must be in the initial presentation of decompensation in severe alcohol-associated hepatitis ii. Must have an absence of a diagnosis of cirrhosis prior to the enrollment hospitalization iii. Must have an absence of a prior diagnosis of alcohol-associated hepatitis 4) Subject is not a candidate for liver transplant and will not become a candidate in the event of worsening conditions.
• • Exclusion Criteria
• • 1. Grade IV West Haven Encephalopathy Criteria
• • 2. Previous liver transplant
• • 3. Currently requires chronic hemodialysis (CRRT or other forms of continuous renal replacement are allowed).
• • 4. 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.
• • 5. Liver injury due to trauma
• • 6. Any current liver cancer
• • 7. Currently on medications with a narrow therapeutic index
• • 8. Platelet count \< 40,000 μL
• • 9. If the subject is intubated and has an acute lung injury
• 10. 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
• • 11. Female that is currently pregnant, planning to be pregnant, or currently breastfeeding
• • 12. Refusal to receive blood products