This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.

This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.

Inclusion Criteria:

• International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
• Venous ammonia level of ≥ 100 μmol/L

Exclusion Criteria:

• Patients who are pregnant