An Open Label, Single Arm, Dose Escalation Phase 1 Trial of PRI-724 in Patients With HCV-induced Cirrhosis

Exclusion Criteria

• •1. Patients with cirrhosis due to causes other than hepatitis C virus; or patients with cirrhosis due to unknown causes.
• •2. Patients with a history of primary liver cancer or a complication thereof.
• •3. Patients with a complication of malignant tumor or a history thereof (within 5 years prior to screening).
• •4. Patients in whom such active viral infections as HBV, HIV or ATCL or syphilis infection cannot be ruled out.
• •5. Patients with serum creatinine \>1.5 times over upper normal or creatinine clearance =\<60 mL/min/1.73 m2.
• •6. Patients with hemoglobin \<8 g/dL.
• •7. Patients with platelet count \<50,000 /\&micro;L.
• •8. Patients with T.Bil =\>3.0 mg/dL.
• •9. Patients with a complication of poorly controlled diabetes, hypertension or heart failure.
• •10. Patients with a complication of mental disorder requiring treatment.
• •11. Patients with serious allergy to contrast media or a history thereof.
• •12. Patients with allergy to inactive ingredients of the study drug.
• •13. Patients who have received interferon, ribavirin or anti-HCV agents within 12 weeks before registration in this study.
• •14. When the medical treatment to a primary disease is carried out, Patient who was changed the dosage and administration within the 12 weeks before registration.
• •15. Patients with a history of drug or alcohol addiction within five years at the time of providing written consent or a history of drug or alcohol abuse within the past one year.
• •16. The patient who received a liver transplant or other organ transplants (a bone marrow transplantation is included), and the patient for whom intravenous administration and venous access are difficult.
• •17. Patients contraindicated for liver biopsy.
• •18. Female patients who are pregnant or suspected to be pregnant; or those who desire to get pregnant during the study period or those of childbearing potential.
• •19. Male patients who do not consent to practice birth control during the clinical study.