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 Overview
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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.

Official Title
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A Phase 3 Study of MP-424 in Combination With IFN Beta and RBV, in Subjects With Genotype 1/2 Hepatitis C, Who Are Treatment-Naïve or Have Received Interferon Based Therapy

Conditions
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Chronic Hepatitis C(CHC)

Intervention / Treatment
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* Drug: MP-424
* Drug: RBV(24 weeks)
* Drug: IFN beta(24 weeks)
* Drug: RBV(48 weeks)
* Drug: IFN beta(48 weeks)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP-424+RBV+IFN beta, Genotype1<br> | Drug: MP-424<br>* MP-424: 750mg every 8 hours (q8h) for 12 weeks<br>Drug: RBV(24 weeks)<br>* RBV: 600 - 1000mg/day based on body weight for 24 weeks<br>Drug: IFN beta(24 weeks)<br>* IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks<br>|
| Experimental: RBV+IFN beta, Genotype1<br> | Drug: RBV(48 weeks)<br>* RBV: 600 - 1000mg/day based on body weight for 48 weeks<br>Drug: IFN beta(48 weeks)<br>* IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks<br>|
| Experimental: MP-424+RBV+IFN beta, Genotype2<br> | Drug: MP-424<br>* MP-424: 750mg every 8 hours (q8h) for 12 weeks<br>Drug: RBV(24 weeks)<br>* RBV: 600 - 1000mg/day based on body weight for 24 weeks<br>Drug: IFN beta(24 weeks)<br>* IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response) |  | 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response) |  | 4 weeks | 
| Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response) |  | 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta) | 
| Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration |  | 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta) | 
| Transition of Serum HCV RNA Levels |  | 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. | From baseline to 24 weeks after completion of drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Feron