Efficacy and Safety of MP-424/Peginterferon Alfa-2b/Ribavirin Combination in Treatment-Naïve Patients With Chronic Hepatitis C

A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Treatment-Naïve Subjects With Genotype 1 Hepatitis C

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b (PEG-IFN) and Ribavirin (RBV) in treatment-naïve patients with (Genotype 1) hepatitis C.

Inclusion Criteria:

• Genotype 1, chronic hepatitis C
• Treatment-naïve (patient who has received no previous interferon based treatment for hepatitis C)
• Able and willing to follow contraception requirements

Exclusion Criteria:

• Cirrhosis of the liver or hepatic failure
• Hepatitis B surface antigen-positive or HIV antibodies-positive
• History of, or concurrent hepatocellular carcinoma
• History of, or concurrent depression, schizophrenia; or suicide attempt in the past
• Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant