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

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Interferon alpha-2; Interferon-alpha; Peginterferon alfa-2a

Criteria

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