miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial (NCT06285253) | Clinical Trial Compass
CompletedPhase 1
miroliverELAP® for the Treatment of Acute Liver Failure: A Phase 1 Trial
United States10 participantsStarted 2024-10-05
Plain-language summary
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.
Who can participate
Age range18 Years – 80 Years
SexALL
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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
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