Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment

This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Inclusion Criteria:

• Genotype 1 CHC
• treatment-naïve or relapsers (patient who relapsed after previous treatment)
• Able and willing to follow contraception requirements

Exclusion Criteria:

• Cirrhosis of the liver or hepatic failure
• Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) 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