Emergency Use of OCR-002 in Acute Liver Failure (ALF)

Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure

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