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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)

NCT01753570 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-06

Study results available
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Summary

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.

Conditions

  • Chronic Hepatitis C(CHC)

Interventions

DRUG

MP-424

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

DRUG

RBV(24 weeks)

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

DRUG

IFN beta(24 weeks)

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

DRUG

RBV(48 weeks)

RBV: 600 - 1000mg/day based on body weight for 48 weeks

DRUG

IFN beta(48 weeks)

IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

Sponsors & Collaborators

  • Toray Industries, Inc

    collaborator INDUSTRY

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Kazuoki Kondo, M.D. · Tanabe Pharma Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01753570 on ClinicalTrials.gov