- Patients with active liver or renal disease based upon liver profile of SGOT > 2 x ULN (upper limit of normal), and/or conjugated bilirubin > 2 x ULN, and/or renal insufficiency (serum creatinine < 2.0 mg/dL, and/or any clinically significant laboratory value based on clinical history which the investigator feels may affect the evaluation of the patient.