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

Tanabe Pharma Corporation54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C (CHC)

Interventions

MP-424DRUG

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

RBVDRUG

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

PEG-IFN alfa-2aDRUG

PEG-IFN alfa-2a: 180mcg/week for 24 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

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: 48 weeks

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: 24 weeks

Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration

Time frame: 36 weeks

Transition of Serum HCV RNA Levels

Time frame: 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)

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

Data from ClinicalTrials.gov

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