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Completed

NCT Number: NCT01753570

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)

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.

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Key information

Conditions

Chronic Hepatitis C(CHC) Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toranomon Hospital

Kawasaki, Takatsu-ku, 213-8587, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MP-424

Drug

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

RBV(24 weeks)

Drug

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

IFN beta(24 weeks)

Drug

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

RBV(48 weeks)

Drug

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

IFN beta(48 weeks)

Drug

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

Primary outcomes

  1. Undetectable HCV (Hepatitis C Virus) RNA (Ribonucleic Acid) at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)

    Time frame: 72 weeks(RBV+IFN beta), 48 weeks(MP-424+RBV+IFN beta)

Secondary outcomes

  1. Undetectable HCV RNA at 4 Weeks After Beginning of Drug Administration (RVR, Rapid Viral Response)

    Time frame: 4 weeks

  2. Undetectable HCV RNA at Completion of Drug Administration (ETR, End-of-treatment Response)

    Time frame: 48 weeks(RBV+IFN beta), 24 weeks(MP-424+RBV+IFN beta)

  3. Undetectable HCV RNA at 12 Weeks After Completion of Drug Administration

    Time frame: 60 weeks(RBV+IFN beta), 36 weeks(MP-424+RBV+IFN beta)

  4. Transition of Serum HCV RNA Levels

    Time frame: Baseline，Day2，Day3，1Week，2Weeks，3Weeks，4Weeks，12Weeks，End of treatment，Follow-up 12weeks，Follow-up 24weeks

  5. Number of Participants With the Emergence of Resistance-associated Variants After MP-424 Administration at the Non-structural 3 Protease Region of HCV.

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

    To examine the emergence of resistance-associated variants after MP-424 administration.

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Collaborators

  • Toray Industries, Inc

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 20, 2012
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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