Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Chronic Hepatitis C Who Have Not Achieved an Undetectable HCV RNA Level With Previous Interferon Based Therapy

Tanabe Pharma Corporation32 enrolled

Overview

This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and RBV in patients with (Genotype 1) hepatitis C, who did not respond to previous treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

MP-424DRUG

750 mg every 8 hours for 12 weeks

RibavirinDRUG

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

Peginterferon Alfa-2bDRUG

1.5 mcg/kg/week for 24 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Genotype 1, chronic hepatitis C * Non-responders (patient who did not respond to 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 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

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

Time frame: After 24 weeks of follow-up

Data from ClinicalTrials.gov

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