Efficacy and Safety of MP-424, Interferon Beta (IFN Beta), and Ribavirin(RBV) in Treatment-Naïve or Having Received Interferon Based Therapy With Chronic Hepatitis C (CHC)

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Collaborator: Toray Industries, Inc
• Treatments: Interferon-beta; Interferons

Criteria

Inclusion Criteria:

• Genotype 1 or 2, chronic hepatitis C, with depression(including the past)

• Treatment-naïve(Genotype 1 only) or patient who have ever had previous IFN based treatment

• 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 serious depression, schizophrenia, or suicide attempt in the past

• Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant