- Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver Confidential - 20 - Amended Clinical Study Protocol v01 / Track Changes Study No. CSOM230CIC01T metastases or ALT or AST more than 5X ULN for patients with documented liver metastases