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)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis C(CHC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MP-424+RBV+IFN beta, Genotype1

Group Type EXPERIMENTAL

IFN beta(24 weeks)

Intervention Type DRUG

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks

MP-424

Intervention Type DRUG

MP-424: 750mg every 8 hours (q8h) for 12 weeks

RBV(24 weeks)

Intervention Type DRUG

RBV: 600 - 1000mg/day based on body weight for 24 weeks

RBV+IFN beta, Genotype1

Group Type EXPERIMENTAL

RBV(48 weeks)

Intervention Type DRUG

RBV: 600 - 1000mg/day based on body weight for 48 weeks

IFN beta(48 weeks)

Intervention Type DRUG

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

MP-424+RBV+IFN beta, Genotype2

Group Type EXPERIMENTAL

IFN beta(24 weeks)

Intervention Type DRUG

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks

MP-424

Intervention Type DRUG

MP-424: 750mg every 8 hours (q8h) for 12 weeks

RBV(24 weeks)

Intervention Type DRUG

RBV: 600 - 1000mg/day based on body weight for 24 weeks

Interventions

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IFN beta(24 weeks)

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks

Intervention Type DRUG

RBV(48 weeks)

RBV: 600 - 1000mg/day based on body weight for 48 weeks

Intervention Type DRUG

IFN beta(48 weeks)

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

Intervention Type DRUG

MP-424

MP-424: 750mg every 8 hours (q8h) for 12 weeks

Intervention Type DRUG

RBV(24 weeks)

RBV: 600 - 1000mg/day based on body weight for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No