Efficacy and Safety of MP-424, Peginterferon Alfa-2a (PEG-IFN Alfa-2a), and Ribavirin(RBV) in Treatment-Naïve or Relapsed Hepatitis C

Study Overview
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Brief Summary
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This study will evaluate the efficacy and safety of MP-424 with PEG-IFN Alfa-2a and RBV in patients with genotype 1 hepatitis C, who are naïve to its treatment or relapsed after previous treatment.

Official Title
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A Phase 3 Study of MP-424 in Combination With PEG-IFN Alfa-2a and RBV, in Subjects With Genotype 1 Hepatitis C, Who Are Treatment-Naïve or Relapsed After Previous Treatment

Conditions
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Chronic Hepatitis C (CHC)

Intervention / Treatment
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* Drug: MP-424
* Drug: RBV
* Drug: PEG-IFN alfa-2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Genotype 1 CHC treatment-naïve or relapsers (patient who relapsed after previous treatment) Able and willing to follow contraception requirements Exclusion Criteria: Cirrhosis of the liver or hepatic failure Hepatitis B surface antigen-positive or HIV (Human Immunodeficiency Virus) antibodies-positive History of, or concurrent hepatocellular carcinoma History of, or concurrent 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: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment-Naive<br> | Drug: MP-424<br>* MP-424: 750mg every 8 hours (q8h) for 12 weeks<br>Drug: RBV<br>* RBV: 600 - 1000 mg/day based on body weight for 24 weeks<br>Drug: PEG-IFN alfa-2a<br>* PEG-IFN alfa-2a: 180mcg/week for 24 weeks<br>|
| Experimental: Treatment-Relapsed<br> | Drug: MP-424<br>* MP-424: 750mg every 8 hours (q8h) for 12 weeks<br>Drug: RBV<br>* RBV: 600 - 1000 mg/day based on body weight for 24 weeks<br>Drug: PEG-IFN alfa-2a<br>* PEG-IFN alfa-2a: 180mcg/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) |  | 48 weeks | 

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) |  | 24 weeks | 
| Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration |  | 36 weeks | 
| Transition of Serum HCV RNA Levels |  | baseline，Day2，Day3，1Weeks，2Weeks，3Weeks，4Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks | 
| Viral Sequencing at the Non-structural 3 Protease Region of HCV Virus（Result of Resistance-associated Variants Analysis) |  | 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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Pegasys