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)

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C(CHC)

Treatments: Drug: MP-424; Drug: RBV(48 weeks); Drug: IFN beta(24 weeks); Drug: RBV(24 weeks); Drug: IFN beta(48 weeks)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753570

G060-F1

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups

MP-424+RBV+IFN beta, Genotype1

Experimental group

Treatment:

Drug: RBV(24 weeks)

Drug: IFN beta(24 weeks)

Drug: MP-424

RBV+IFN beta, Genotype1

Experimental group

Treatment:

Drug: IFN beta(48 weeks)

Drug: RBV(48 weeks)

MP-424+RBV+IFN beta, Genotype2

Experimental group

Treatment:

Drug: RBV(24 weeks)

Drug: IFN beta(24 weeks)

Drug: MP-424