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 Corporation74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C(CHC)

Interventions

MP-424DRUG

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

RBV(24 weeks)DRUG

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

IFN beta(24 weeks)DRUG

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

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Toranomon Hospital

Kawasaki, Takatsu-ku, Japan

Outcomes

Primary Outcomes

Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

Time frame: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)

Secondary Outcomes

Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)

Time frame: 4 weeks

Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)

Time frame: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)

Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration

Time frame: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)

Transition of Serum HCV RNA Levels

Time frame: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks

Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.

To examine the emergence of resistance-associated variants after MP-424 administration.

Time frame: From baseline to 24 weeks after completion of drug administration

Data from ClinicalTrials.gov

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